LIFEPAK 1000 Are Being Recalled. Our firm is investigating potential lawsuits involving the LIFEPAK 1000 automatic external defibrillator (AED), manufactured by Physio-Control. These external defibrillators are used during emergency situations when the patient has sudden cardiac arrest, where the heart stops beating. AEDs deliver a shock to the heart, allowing it to regain its normal rhythm. In 2017, the LIFEPAK 1000 was recalled because it can shut down unexpectedly during use, failing to deliver life-saving therapy.
Physio-Control said it received 34 reports of unexpected shut downs, and 8 adverse events. Regulators in both the United States and Europe addressed the recall. The U.S. Food and Drug Administration (FDA) placed its most serious Class I status on the recall.
If you or someone you know is interested in filing a lawsuit over the LIFEPAK 1000 defibrillator, contact one of our experienced product liability attorneys at Parker Waichman LLP. Our firm offers free, no-obligation legal consultations.
Physio-Control Recalls LIFEPAK 1000 Defibrillator Due to Unexpected Shut Down
In a Jan. 13, 2017 press release posted on the FDA website, Physio-Control said it launched a “voluntary field action” for the LIFEPAK 1000 defibrillator. The company initiated the action following reports where the AED shut down unexpectedly while being used on a patient.
Physio-Control says it received 34 reports where the LIFEPAK 1000 AED shut down unexpectedly. This issue is associated with 8 adverse events. According to the release, the shutdown stems from “an intermittent connection between the battery and device electrical contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death.”
The AED shuts down unexpectedly because wear and oxidation formation occurs between the battery and device electrical contracts, leading to intermittent connection, the company said. Defibrillators that have been exposed to vibration or have an older battery may be more susceptible to this issue. While the problem can occur with any LIFEPAK 1000 device, Physio-Control says it is more likely to occur when there is a non-rechargeable battery that is not routinely removed for inspection as listed on the instructions.
“The company has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. This condition can occur over time in LIFEPAK 1000 devices that are exposed to vibration and have a battery installed for long periods of time,” the announcement reads. “This issue can potentially affect any LIFEPAK 1000 device, however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the LIFEPAK 1000 Defibrillator Operating Instructions, are more susceptible to this issue.”
Customers are advised to immediately remove and reinstall the battery on the affected defibrillators. Additionally, Physio-Control says all LIFEPAK 1000 devices should undergo a weekly battery removal and reinstallation. The company says this weekly regimen will “clean the contacts of oxidation” and reduce the risk of unexpected shut downs.
In March 2017, the FDA designated the recall as Class I, the agency’s most serious recall status. Class I recalls indicate that exposure to the recalled device presents a reasonable risk of serious injury or death. The update states, “Physio-Control has determined that wear and oxidation formation between the battery and device electrical contacts may cause power interruptions. Physio-Control anticipates contacting customers in May 2017, to schedule a hardware device correction for the LIFEPAK 1000 devices, which includes modifying the power control circuit board of the device and placing dielectric lubrication on the battery and device contacts.”
If the defibrillator shuts down when treatment is needed, the patient may suffer permanent organ damage, brain injury or death.
According to the FDA notification, 50,046 LIFEPAK 1000 defibrillators are affected by the recall with product numbers 320371500XX. The recall affects 133,330 serial numbers between June 30, 2006 and Dec. 20, 2016.
In its “Urgent Medical Device Correction” letter, Physio-Control asked customers to inform all relevant staff of the issue and follow instructions provided. Customers were instructed to promptly remove and reinstall the battery from the AED, as this will clean the contacts of oxidation and restore power to the LIFEPAK 1000 defibrillator. The company also instructed customers to remove and reinstall batteries weekly to prevent an unexpected shut down. The letter also emphasized the importance of carrying a spare, fully charged battery.
Physio-Control says that if the LIFEPAK 1000 AED shuts down unexpectedly, the battery should be removed and installed immediately. If this does not return power to the device, a spare battery should be used and customers should call the company right away to service the device. “If the device powers off unexpectedly, either during inspection or during patient treatment, immediately remove and reinstall the existing battery to restore power to the device. If power is not restored, replace the battery with a spare battery and call Physio-Control immediately to arrange for servicing of the device,” the recall announcement states.
The company also includes a “Battery Inspection Checklist”, to encourage customers to remove and reinstall batteries weekly.
“Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and the company will contact customers to schedule device corrections once the hardware correction is ready for implementation.”
LIFEPAK 1000 AED Recalled in the UK
The LIFEPAK 1000 defibrillator recall is not limited to the United States. The Medicines Healthcare Products Regulatory Agency (MHRA) of the United Kingdom also addressed the issue in May 2017. Physio-Control UK issued an Urgent Field Safety Notice warning that its defibrillators could shut down unexpectedly due to an intermittent connection between the battery and device contacts.
According to The Sun, the recall could affect 1,000 of 10,068 devices in the UK. LIFEPAK defibrillators can be found in public places such as schools, airports, football stadiums and leisure centers, in addition to clinical setting such as hospitals, clinics and ambulances.
“These devices deliver life-saving treatment and it is vital they operate correctly when needed in an emergency,” said John Wilkinson, MHRA’s Director of Medical Devices, according to The Sun. “People who are responsible for them should carry out the checks recommended by the manufacturer.”
What is the LIFEPAK 1000 AED?3>
The LIFEPAK 1000 is an external defibrillator that can be used by medical professionals and individuals trained in CPR. The device is used to treat sudden cardiac arrest, when the heart stops beating unexpectedly. When this happens, the vital organs do not receive the blood they need to function. AEDs are used to deliver a shock, with the hopes that the heart will start beating normally once again.
To use the LIFEPAK 1000, electrodes are attached to the patient. The device analyzes the heart rhythm to determine whether a shock is needed.
Parker Waichman is investigating product liability lawsuits on behalf of LIFEPAK 1000 AED users. The law holds manufactures liable for products that are dangerous or defective to users. Drug and medical devices are frequently named in product liability claims.
Filing a LIFEPAK 1000 AED Recall
If you or someone you know has questions about filing a LIFEPAK 1000 AED Recall Lawsuit, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).