MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	AUX3100S19
Health Effect - Clinical Code	Hypoventilation (1916)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a bipap a40 pro was inadequately ventilating the patient and the patient was admitted to the hospital for hypercapnia.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported a bipap a40 pro was allegedly inadequately ventilating the patient and the patient was admitted to the hospital for hypercapnia.Despite of three attempts 07/18/2022, 08/15/2022 and 09/08/2022; the device has not yet returned to the manufacturer for evaluation.There was no response from the customer to have the device returned.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 A40 PRO
• 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: 12474510
• Report Number: 2518422-2021-03462
• Device Sequence Number: 14438149
• Product Code: MNS
• UDI-Device Identifier: 00606959059177
• UDI-Public: 00606959059177
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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: Health Professional
• Device Model Number: AUX3100S19
• Device Catalogue Number: AUX3100S19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• 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: Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female