|
Device Problems
Degraded (1153); Product Quality Problem (1506)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/15/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
No device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973 and z-1974.H3 other text : device not returned to manufacturer.
|
|
Event Description
|
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received voluntary medwatch (mw5147231) alleging her mask leaking/not working correctly and there were white dust particles.There was no report of serious patient harm or injury.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.
|
|
Search Alerts/Recalls
|
|
|