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

Model Number 1109596

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Hypoventilation (1916)

Event Date 09/03/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred and "the device defaulted back to the factory settings".The patient was admitted to the hospital for hypercarbia with the thought that they were hypo-ventilating due to default settings".Further information confirmed that the patient was not admitted to the hospital.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was not confirmed for the ventilation in-op and for the device defaulting back to the factory settings.Additional findings not related to the malfunction/issue were the heated humidifier (see ra# (b)(4)) and detachable battery module (see ra# (b)(4)) for this device.

• Brand Name: BIPAP A40
• Type of Device: VENTILATOR,CONTINUOUS,MINIMAL VENTILATOR 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: 18763544
• MDR Text Key: 336053222
• Report Number: 2518422-2024-09271
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2024

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: Other
• Device Model Number: 1109596
• Device Catalogue Number: 1109596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Initial Date Manufacturer Received: 09/03/2015
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other