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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. BIPAP AVAPS CSERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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PHILIPS RESPIRONICS INC. BIPAP AVAPS CSERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Model Number 1167P
Medical Device Problem Code Degraded (1153)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/01/2021
Type of Reportable Event Death
Event or Problem Description
The manufacturer received information alleging a bipap device's sound abatement foam became degraded.The patient expired in (b)(6) 2021.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
 
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Brand Name
BIPAP AVAPS CSERIES
Common Device Name
VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
Manufacturer (Section D)
PHILIPS RESPIRONICS INC.
1001 murry ridge lane
murrysville PA 15668
MDR Report Key12388129
Report Number2518422-2021-03607
Device Sequence Number4815402
Product Code MNS
UDI-Device Identifier00606959039261
UDI-Public00606959039261
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K102465
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number1167P
Device Catalogue Number1167P
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/26/2021
Initial Report FDA Received Date08/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		RES 88058
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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