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Supplier |
Number |
Description |
Medsafe Contact |
Remaining |
|
Pulmonetics Systems |
1 |
Level of recall
This action has been classified by the Food and Drug Administration (FDA) as a Class I Recall.Medical Device Recall
LTV series ventilators with the following serial numbers are
LTV 1000 A02863
LTV 1000 A01252
LTV 1000 A01693
LTV 1000 A05506
LTV 900 B01333
LTV 900 B01584
Recall Reason
The ventilators malfunction when switching to the internal battery when the external power source is inadequate. There is the remote possibility that when switching to internal battery operation, the ventilator may not operate after disconnecting from an inadequate external power supply, if the internal battery is not properly charged. External DC power sources include three and nine hour lead-acid batteries as well as automobile batteries powering the ventilator through a cigarette lighter adapter.
Action to be Taken
As identified in the Safety Alert, and as part of ventilator patient care, caregivers should always be prepared to provide alternate means of ventilation should any product malfunction occur.
Further Information
Pulmonetic Systems, Inc., Minneapolis, Minnesota, is voluntarily initiating a recall of approximately 10,000 of its portable ventilators intended for mechanical ventilation of adults and children in homecare, hospitals and other institutions. The ventilators being recalled were manufactured before September 1, 2003.
The ventilators malfunction when switching to the internal battery when the external power source is inadequate. This problem causes failure of the ventilator to breathe for the patient, which could result in permanent neurologic injury or death.
A Safety Alert, accompanied by a Caregiver Information Sheet, is attached to this Recall notice. |
$Robert |
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