|
Device Problem
Degraded (1153)
|
Patient Problem
Solid Tumour (4552)
|
Event Date 08/28/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Since 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 : the device has not yet been returned to the 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 information alleging an issue related to a philips cpap device's sound abatement foam.The manufacturer received information alleging acoustic neuroma.There is no allegation of serious or permanent harm or injury.No further clinical details or medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
|
Search Alerts/Recalls
|
|
|