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

Model Number	CN1067HS
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a bipap s/t cseries device shut down while in patient use.The patient was cyanotic and tachycardic.The patient was placed on another non invasive ventilator and the patient recovered.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a bipap s/t cseries device allegedly shut down while in patient use.The patient was cyanotic and tachycardic.The patient was placed on another non invasive ventilator and the patient recovered.Despite several attempts to have the device returned for evaluation and investigation were unsuccessful.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.

• Brand Name: BIPAP S/T CSERRIES
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12828526
• Report Number: 2518422-2021-06897
• Device Sequence Number: 16517022
• Product Code: MNS
• UDI-Device Identifier: 00606959015753
• UDI-Public: 00606959015753
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: Health Professional
• Device Model Number: CN1067HS
• Device Catalogue Number: CN1067HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown