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

Model Number	CAX500T12W
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Respiratory Tract Infection (2420); Cancer (3262); Cough (4457); Unspecified Hepatic or Biliary Problem (4493); Unspecified Kidney or Urinary Problem (4503)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient was diagnosed with bladder cancer and required surgery.The details of the patient's required medical intervention are unknown.The manufacturer has attempted to arrange for the return of the device to the manufacturer's product investigation lab.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 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.
Additional Manufacturer Narrative
The manufacturer previously received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient was diagnosed with bladder cancer and required surgery.The details of the patient's required medical intervention are unknown.In the initial report, b3 date was incorrect, which is updated in this report.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of device were completed by the manufacturer and found evidence of unknown contaminant on the ui knob on the front panel, on the iso port, on the rear panel, and on the bottom enclosure externally.Internal investigation shows unknown contaminant on the top enclosure and front panel, a dust contaminant on the front panel, an unknown contaminant on the blower cap, an unknown dust contaminant on the bottom enclosure, an unknown contaminant on the blower seal, liquid ingress with mineral deposits on the blower and blower box, keratin-like substance on the blower box outlet.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no errors logged.The device was applied power and the device operated properly.The manufacturer concludes multiple contaminates found were inconsistent with sound abatement foam degradation and a dust contaminant on the front panel, liquid ingress with mineral deposits on the blower and blower box, keratin-like substance on the blower box outlet were consistent with the sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 12145568
• Report Number: 2518422-2021-02119
• Device Sequence Number: 11804742
• Product Code: BZD
• UDI-Device Identifier: 00606959034693
• UDI-Public: 00606959034693
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2023

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: CAX500T12W
• Device Catalogue Number: CAX500T12W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 03/29/2023
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/09/2021; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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