MAUDE Adverse Event Report: RESPIRONICS, INC BIPAP AUTOSV ASSY 60 SRS 30CM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	960T
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused cancer.The patient did not receive medical intervention.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.  additional information was received and section b5 should be reported as:   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 received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged to experience a cancer.There was no medical intervention required by the patient.The reported event of cancer and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.  the device has not yet returned to the manufacturer for evaluation.The patient has swapped out the deice at the distributor and at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.  section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.

• Brand Name: BIPAP AUTOSV ASSY 60 SRS 30CM
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 muury ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 muury ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 501 living place; pittsburg, PA 15206 ; 2673970028
• MDR Report Key: 12961740
• Report Number: 2518422-2021-07875
• Device Sequence Number: 5424097
• Product Code: MNS
• UDI-Device Identifier: 00606959037991
• UDI-Public: 00606959037991
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: 960T
• Device Catalogue Number: 960T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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: Other
• Patient Sex: Unknown