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

Model Number AUX3100S19

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hypoventilation (1916)

Event Date 08/20/2021

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 271568083
• Report Number: 2518422-2021-03462
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959059177
• UDI-Public: 00606959059177
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AUX3100S19
• Device Catalogue Number: AUX3100S19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female