MAUDE Adverse Event Report: RESPIRONICS,INC DREAMSTATION AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CAX700T12
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused the patient to be diagnosed with throat cancer.The patient did not report receiving any 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 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 bipap device's sound abatement foam and became degraded and caused the patient to be diagnosed with throat cancer.The medical intervention that the patient received in response to the event is currently unknown.The device was returned to the manufacturer's service center for further evaluation.The evidence of sound abatement foam degradation/breakdown was not observed in the base unit but the device was evaluated and slight dust/dirt contamination top and bottom enclosures, ui panel, rear panel, sd cover flip door, accessory module flip door, control dial, dc jack color insert,p4 power connector, and blower box, suggesting a source external to the device.Unknown contaminate inside ui panel, dc jack color insert, bottom enclosure, rear panel.Discoloration on blower box upper cap.White powder like substance on blower, blower box, blower box upper cap, and rear panel o-ring.Corrosion on p4 power connector.Liquid ingress with mineral deposits were observed on the blower and p4 power connector.A contaminate consistent with kertain was observed on the blower box.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.The manufacturer found no errors.The manufacturer concludes that they could not confirm the customer's allegation and there is dust / dirt contamination and the presence of contamination in the airpath, source of contaminations were external to the device.

• Brand Name: DREAMSTATION AUTO BIPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 12817661
• Report Number: 2518422-2021-06718
• Device Sequence Number: 4787577
• Product Code: BZD
• UDI-Device Identifier: 00606959026667
• UDI-Public: 00606959026667
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: CAX700T12
• Device Catalogue Number: CAX700T12
• 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: 09/08/2023
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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: Male