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

Model Number 1111177

Device Problem Unexpected Shutdown (4019)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 08/16/2022

Event Type  Death  

Event Description

The manufacturer received information alleging a bipap a40 device quit operating while in patient use.The patient's condition took a turn for the worse and expired.The device is in the possession of the police.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported receiving information alleging bipap a40 device quit operating while in patient use.The patient's condition took a turn for the worse and expired.The device is in the possession of the police.The device was returned to the customer to manufacturer service centre.The alarm log revealed that "battery depleted" alarm occurred while the device was running on a detachable battery, a possible cause was that dust went into the device and the pressure sensor/flow sensor temporarily malfunctioned.Therefore, the main board was replaced.A life-related smell was observed.The device's ui panel, blower assembly, outlet flow path, right side assembly was replaced.

Manufacturer Narrative

The manufacturer received information alleging a bipap a40 device quit operating while in patient use.The patient's condition took a turn for the worse and expired.The device is in the possession of the police.The ventilator was returned to the manufacturer for evaluation, and the reported phenomenon was not duplicated.The alarm log revealed that the "battery depleted" alarm occurred while the device was running on a detachable battery only.In addition, the "ventilator inoperative" alarm had been recorded, and the drpt revealed that e-46 and e-47 (error) had been recorded.A possible cause was that dust went into the device and the pressure sensor or flow sensor temporarily malfunctioned.Therefore, the main board was replaced.A life-related smell was observed.The following parts were replaced: ui panel, blower assembly, outlet flow path, and right side assembly.After the replacements, it was ensured that the phenomena were resolved.Overall checking, cleaning, and a functional test were performed.The manufacturer's product investigation laboratory performed investigation installed the pca on a new unused surrogate a-40 and ran the unit at the received settings with ac power and dc power with a passive mechanical lung.The unit did not give any unusual errors.All indications are the unit operates as expected.

• Brand Name: BIPAP A40
• 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 15206 ; 2673970028
• MDR Report Key: 15292289
• MDR Text Key: 298564095
• Report Number: 2518422-2022-75543
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

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: Lay User/Patient
• Device Model Number: 1111177
• Device Catalogue Number: 1111177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 01/15/2023; 01/17/2024
• Supplement Dates FDA Received: 07/31/2023; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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): Death
• Patient Age: 29 YR
• Patient Sex: Female