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Press Release from Arjo, Inc. Regarding Recall of Arjo MINSTREL Patient Lifts

Wed, 26 May 2004 00:00:00 -0700

For Immediate Release:

May 26, 2004

ARJO, INC Announces a Nationwide, Voluntarily Recall of the MINSTREL Patient Lifts

Contact:
Arjo, Inc.
Quality Assurance Department
1.800.323.1245, ext. 6140 or 6103

Arjo, Inc. today announced that it is voluntarily conducting a Class I recall for two models, HMB001-US (with out scale) and HMB002-US (with scale) of its MINSTREL Patient Lifts because of mechanical problems that could result in serious patient injury. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of the product will cause serious adverse health consequences or death.

Arjo is aware of reports of the hanger bar falling off the lift, causing the patient to fall and be injured. One of these incidents resulted in death.

This recall involves 116 MINSTREL Patient Lifts that could possibly result in hanger bar detachment due to pin migration or pin breakage in the hanger bar assembly. No other Arjo, Inc. devices are involved in this action.

All affected customers were formally notified via certified mail of the MINSTREL Field Correction/Recall on April 30, 2004. Affected customers have already been advised to exercise the option of inspecting their MINSTREL Patient Lift and completing an Inspection Form or removing their MINSTREL Patient Lift from use pending repair from an authorized Arjo Service Technician. Affected customers have also been advised to complete a Customer Response Form and return it to Arjo, Inc. Quality Assurance Department.

Appropriate corrective action was taken to eliminate the MINSTREL problem and 100 units have already been repaired. The remaining 16 MINSTREL Lifts will be repaired by May 28, 2004.

Arjo, Inc. is voluntarily cooperating with the Food and Drug Administration to ensure that all affected customers are notified of this issue. Arjo, Inc. formally notified the Food and Drug Administration on April 28, 2004.

Arjo, as a global leader in patient lifts, is committed to ongoing product surveillance to assure product safety and reliability.

Any inquiries regarding this action should be directed to the Quality Assurance Department using the above referenced toll-free number.

Class 1 Recall: Arjo MINSTREL Patient Lifts

Fri, 30 Apr 2004 00:00:00 -0700

Date Recall Initiated:
April 30, 2004

Product:
MINSTREL Patient Lifts, models HMB001-US (without scale) and HMB002-US (with scale).

Use: The device is a battery powered patient lift. Patient lifts are intended to be used to lift and transport patients from one location to another, such as from a bed to a bath.

Recalling Firm:
Arjo, Inc.
50 North Gary Avenue
Roselle, IL 60172

Reason for Recall:

There are two mechanical problems for which the MINSTREL patient lift is currently being recalled. The first involves the hanger bar detaching from the lift resulting in the patient falling to the ground because of a missing spring washer. The second problem involves a bolt in the foot pedal assembly becoming loose which allows the foot pedal assembly to fall off of the lift. This results in the lift becoming unstable and the patient possibly falling.

Public Contact:
Ms. Brenda Ammonette
Quality Assurance Manager
800-323-1245
FDA District:
Chicago

FDA Comment:
Facilities should either inspect their MINSTREL lifts and follow the instructions in the MINSTREL Field Correction/Recall letter sent to all facilities or they should take the lifts out of service until they can be inspected by an Arjo service engineer. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.

For additional information on this product recall, see the Arjo Inc. press release at: http://www.fda.gov/cdrh/recalls/recall-043004-pressrelease.html or call Arjo Inc. at 1-800-323-1245, ext. 6140 or 6103.

Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00850.html. Scroll down to "Recalls and Field Corrections: Devices – Class I".

Minstrel Patient Lift Defective Medical Device Recall Lawyers

Fri, 30 Apr 2004 00:00:00 -0700

Minstrel Patient Lift

Arjo, Inc. today announced that it is voluntarily conducting a Class I recall for two models, HMB001-US (without scale) and HMB002-US (with scale) of its MINSTREL Patient Lifts because of mechanical problems that could result in serious patient injury. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of the product will cause serious adverse health consequences or death.

The device is a battery powered patient lift. Patient lifts are intended to be used to lift and transport patients from one location to another, such as from a bed to a bath. There are two mechanical problems for which the MINSTREL patient lift is currently being recalled. The first involves the hanger bar detaching from the lift resulting in the patient falling to the ground because of a missing spring washer. The second problem involves a bolt in the foot pedal assembly becoming loose which allows the foot pedal assembly to fall off of the lift. This results in the lift becoming unstable and the patient possibly falling.

This recall involves 116 MINSTREL Patient Lifts that could possibly result in hanger bar detachment due to pin migration or pin breakage in the hanger bar assembly.

If you or a loved one suffered injuries from a Minstrel Patient Lift, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.