MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. BIPAP A30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1074683

Device Problems Contamination (1120); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Death (1802)

Event Date 01/22/2020

Event Type  Death  

Event Description

The manufacturer received information alleging a bipap a30 device had a ventilator inoperative condition while in patient use.The patient expired.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a bipap a30 device allegedly had a ventilator inoperative condition while in patient use.The patient expired.The device was returned to the manufacturer's product investigation laboratory for investigation.During evaluation, the customer's complaint was unable to be duplicated and the device was found to alarm and function as designed.The device's event logs were downloaded and evaluated by the manufacturer.The manufacturer was able to confirm the event log indicates the several ventilator inoperative condition occurred on the date of event.An internal evaluation of the device found evidence of an unknown, external contaminant to the valve assembly, blower and blower housing.The ventilator inoperative alarm condition is likely related to an external contamination of the valve assembly.Product labeling states,"a properly installed, undamaged gray foam filter is required for proper operation.Wash periodically and replace when damaged for proper operation.If you notice any unexplained changes in the performance of the device, if it is making unusual sounds, if the device or detachable battery are dropped, if water is spilled into the enclosure, or if the enclosure is cracked or broken, discontinue use and contact philips respironics or an authorized service center for service.If you are a patient, please contact your home care service provider." the device was returned unrepaired per customer's request.

• Brand Name: BIPAP A30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa PA 15068
• Manufacturer (Section G): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa PA 15068
• Manufacturer Contact: adam price ; 1001 murry ridge lane; murrysville, pa, PA 15068 ; 7243349303
• MDR Report Key: 9672716
• MDR Text Key: 177842727
• Report Number: 2518422-2020-00298
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: K113053
• 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
• Report Date: 01/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1074683
• Device Catalogue Number: 1074683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• 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