|
Device Problem
Degraded (1153)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 04/09/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
No device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.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 patient is threatening legal action.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.No other information has been provided.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
|
Search Alerts/Recalls
|
|
|