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

Model Number 1067P

Device Problem Degraded (1153)

Patient Problem Cardiac Arrest (1762)

Event Date 04/10/2022

Event Type  Death  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 289663167
• Report Number: 2518422-2022-13706
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959039209
• UDI-Public: 00606959039209
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1067P
• Device Catalogue Number: 1067P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Death