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Medical Device Recalls
Class 1 Recall: Pulmonetic Systems LTV Series of Ventilators
See Related Information
Date Recall
Initiated:

September 8, 2004
Product:
 Pulmonetic Systems LTV series of ventilators, models 1000, 950, 900 and 800. Approximately 10,300 devices are in domestic and international distribution.
Use:
 To provide continuous or intermittent breathing support for adult or pediatric patients weighing at least 11 lbs. who require mechanical ventilation. The devices are designed to automatically switch to internal battery operation, allowing uninterrupted ventilation, when an external power source is removed or is no longer adequate to power the ventilator.
Recalling Firm:
 Pulmonetic Systems, Inc.
17400 Medina Road, Suite 100
Minneapolis, MN 55447-1341
Reason for Recall:
 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.
Public Contact:
 Pulmonetic Systems, Inc.
1-800-754-1914, extension 2
FDA District:
 Minneapolis
FDA Comment:
 The company sent a Safety Alert, accompanied by a Caregiver Information Sheet, to customers and users on September 7, 2004. These publications describe the malfunction, the alarms that should occur, and give detailed instructions on how to immediately correct the malfunction and resume appropriate ventilation.

If instructions in the Safety Alert are properly followed, the unit will usually continue to provide ventilation. Caregivers should always be prepared to provide alternate means of ventilation should any product malfunction occur.

The company expects to provide a permanent solution for all affected devices within the next 4-6 weeks. Meanwhile, users and caregivers need to read the Caregiver Information Sheet to understand how to react in the event this malfunction should occur.

Class I recalls are the most serious type of recall and involve situations in which 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 Pulmonetic press release.

Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00867.html. Scroll down to "Recalls and Field Corrections: Devices - Class I".

Updated October 19, 2004

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