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

Model Number 1109596

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/22/2021

Event Type  Death  

Event Description

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused the patient to have a foreign body found in lungs and then expired a month later.The patient received medical intervention in the form of a bronchoscopy during hospitalization.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported a bipap device's sound abatement foam allegedly became degraded and caused the patient to have a foreign body found in lungs and then expired a month later.The patient received medical intervention in the form of a bronchoscopy during hospitalization.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.During the initial visual investigation of the exterior of the device, the device's air inlet showed evidence of being dirty.There was no inlet filter with the returned device.The device's event log was reviewed by the manufacturer and found multiple error codes for patient disconnect alarm.The manufacturer was unable to duplicate this error when the device was tested.The device was turned on and the manufacturer did not confirm the device was emitting an odor.The device was then tested in conjunction with a mechanical quick lung and was found to operate without issue or error codes.The device was disassembled for internal visual inspection.The blower appears to be clean.The flow path contained minimal amount of residue consistent with an external source.The manufacturer found a residue on the inside of the enclosure consistent with being from an external source.The manufacturer visually inspected the air inlet foam and foam on the bottom of the enclosure.All the foam pieces that make up the air inlet path were found to be intact with no visual indications of foam degradation.The manufacturer tested the heated humidifier and confirmed the water chamber was free of debris or residue.The manufacturer concludes there was no evidence of odor or foam degradation within the device.The device operated as designed.

• 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 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12824544
• MDR Text Key: 280865736
• Report Number: 2518422-2021-06844
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959042742
• UDI-Public: 00606959042742
• 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: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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: 1109596
• Device Catalogue Number: 1109596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/17/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Death; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male