MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 SYSTEM SILVER; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number R1111177

Device Problem Activation Failure (3270)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 08/02/2023

Event Type  Injury  

Event Description

The manufacturer received information alleging that the unit no longer operated.A manufacturer's representative visited the patient's home to perform a device check.There were no abnormalities found.The rep received a call after leaving from the patient's family alleging that the therapy button could not be pressed any longer and it was impossible to initiate therapy as the device operation was faulty.The representative advised to use an ambu bag to deliver respirations but upon the representative's arrival, they found the patient waiting for the ambulance.The patient was transported to a hospital by ambulance because the device stopped operating and exhalation efforts failed to be kept.The rep was unable to retrieve the unit.The device has not been returned to the manufacturer.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

H3 other text : device not returned to the manufacturer.

• Brand Name: BIPAP A40 SYSTEM SILVER
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): 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 15208 ; 4125423300
• MDR Report Key: 18012519
• MDR Text Key: 326626705
• Report Number: 2518422-2023-27884
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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
• Device Operator: Other
• Device Model Number: R1111177
• Device Catalogue Number: R1111177
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male