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

Model Number	1116156
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a bipap a40 device's sound abatement foam became degraded and caused severe chest pain.The patient was admitted to the hospital for two weeks.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported mdr 2518422-2021-02475 with the incorrect investigation conclusion code of code 12: cause traced to device design, in section h6.The correct investigation conclusion code is code 11: conclusion not yet available.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.Corrected data: d8 was this device serviced by a third party?: previously reported as no ; updated to unknown.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging a bipap a40 device's sound abatement foam became degraded and caused severe chest pain.The patient was admitted to the hospital for two weeks.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation visually inspected the a40 silver series and did not observe any visual defects.Reviewed error logs and consulted engineering.Nothing abnormal appeared, installed a bacteria filter on the outlet of the unit and ran the unit at the received settings, on an asl lung for an hour at approximately 500ml volume without error.Removed the bacteria filter and inspected it.No foam was observed in the filter.Unit operates as expected.The apnea alarm and the circuit disconnect alarm were checked.Both alarms operated as expected.

• Brand Name: BIPAP A40
• Common Device Name: 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: 12229188
• Report Number: 2518422-2021-02450
• Device Sequence Number: 11978984
• Product Code: MNT
• UDI-Device Identifier: 00606959039537
• UDI-Public: 00606959039537
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/07/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1116156
• Device Catalogue Number: 1116156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021; 08/16/2021; 01/26/2024
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 07/27/2021; 09/15/2021; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown