MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. BIPAP S/T C SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1067P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/10/2022
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient was in the hospital and the patient's blood oxygen level decreased.The device was changed to a different device.The patient expired as a result of a cardiac arrest.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury.
Additional Manufacturer Narrative
The manufacturer previously receiving information alleging an issue related to a bipap device's sound abatement foam.The patient was allegedly in the hospital and the patient's blood oxygen level decreased.The device was changed to a different device.The patient expired as a result of a cardiac arrest.The device is not returning to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported an issue related to a bipap device's sound abatement foam.The patient was allegedly in the hospital and the patient's blood oxygen level decreased.The device was changed to a different device.The patient expired as a result of a cardiac arrest.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The corrected information is: the manufacturer previously reported an issue related to a bipap device's sound abatement foam.The patient was allegedly in the hospital and the patient's blood oxygen level decreased.The device was changed to a different device.The patient expired as a result of a cardiac arrest.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP S/T C SERIES
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14160515
• Report Number: 2518422-2022-13706
• Device Sequence Number: 5932792
• Product Code: MNS
• UDI-Device Identifier: 00606959039209
• UDI-Public: 00606959039209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2022

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 Number: 1067P
• Device Catalogue Number: 1067P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 04/21/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 04/21/2022; 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown