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

Model Number 1076538

Device Problem Unexpected Shutdown (4019)

Patient Problem Respiratory Distress (2045)

Event Date 11/05/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient was in respiratory distress when a bipap a40 device would not function.It is unknown at this time what type of medical intervention was required for the patient.The device has yet to be received for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a patient was in respiratory distress when a bipap a40 device allegedly would not provide therapy.It is unknown what type of medical intervention was required for the patient.The device was returned to the manufacturer's product investigation laboratory for further evaluation.The customer's complaint was not duplicated.The device was tested and was found to operate and alarm to design specifications.The root cause could not be determined.Product labeling states,"the bipap a40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22 lbs) with obstructive sleep apnea (osa), respiratory insufficiency, or respiratory failure.It is intended to be used in home, institutional/hospital, and portable applications such as wheelchairs and gurneys.It is not intended to be used as a transport ventilator, and is not intended for life support." the manufacturer concludes that although the customer's complaint was not duplicated, the device operated to design specifications.

• Brand Name: BIPAP A40
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa PA 15068
• MDR Report Key: 9591481
• MDR Text Key: 175059023
• Report Number: 2518422-2020-00132
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1076538
• Device Catalogue Number: 1076538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention