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FDA Issues Another Recall of Medical Ventilator

Dec 14, 2004 | Newsday

The Food and Drug Administration seldom announces a recall of a recall, but that's essentially what happened when the agency revealed a malfunction in an adaptor meant to correct a potentially deadly defect in a medical ventilator it approved several years ago.

In a statement released Friday, the FDA stated that the manufacturer of a medical ventilator had recalled 1,129 cable adaptors intended to fix an earlier life-threatening problem linked to the device, which helps people breathe. Instead, the adaptors posed new hazards for respiratory patients.

A news release issued by Pulmonetic Systems of Minneapolis the manufacturer of the ventilators said use of the adaptors could lead to "serious injury or death" because they might prevent the ventilator from working. However, Pulmonetic said it had received no death or injury reports connected to the adaptors.

The adaptors were meant to correct an earlier power supply defect. But the adaptors apparently compounded the problem in some cases.

Earlier this year, a Newsday investigation of Pulmonetic's ventilators found reports of 18 deaths associated with the devices had been filed with the FDA. At the time, Pulmonetic officials said that the ventilators were in use when problems occurred, but that the devices didn't actually cause incidents in which patients turned blue from lack of oxygen and alarms failed to sound when the machines stopped working.

In its latest announcement, the FDA stated: "Customers have been asked by the firm to remove the adaptors according to instructions provided to them and return the adaptors to the company."

A Pulmonetic spokesman did not return Newsday's phone call for comment yesterday. FDA officials could not be reached for comment.

The FDA approved Pulmonetic's ventilators in 1998, using a controversial, streamlined approval process.

Pulmonetic Systems' permanent resolution of the ventilator malfunction will be to replace the power circuit board for all affected ventilators made by the company, the FDA announcement stated.

Newsday's investigation earlier this year found that several years ago, Pulmonetic was aware that a circuit board malfunction threatened to cause the devices to stop working without an alarm sounding.

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