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

Model Number	DE962S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	05/01/2021
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop bone cancer.The patient expired in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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 reported an allegation of an issue related to a bipap device's sound abatement foam became degraded and caused a patient to develop bone cancer.The patient expired in response to the reported event.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation, mineral spots consistent with water ingress were found within the blower box and on the motor casing.Confirmed that there was evidence of sound abatement foam degradation or breakdown observed in the base unit.Sound abatement foam appears to have degraded and does not return to its original shape when compressed.In this report, section d9, g3, h3, h6 has been updated.

• Brand Name: BIPAP AUTOSV ADV
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 13169662
• Report Number: 2518422-2022-00321
• Device Sequence Number: 11878453
• Product Code: MNS
• UDI-Device Identifier: 00606959029682
• UDI-Public: 00606959029682
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K092818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: DE962S
• Device Catalogue Number: DE962S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2013
• 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: Death; Death
• Patient Sex: Unknown