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

Model Number	CAX200H12
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.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.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 previuosly received information alleging had to go to emergency to have throat cleared related to a cpap device's sound abatement foam.The patient has alleged to seeing particles in the device.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated and found evidence of sound abatement foam degradation/breakdown was not observed in the base unit.In secondary findings, found evidence of liquid ingress on blower and blower box.Mineral deposits in humidifier water storage tank are consistent with the use of non-distilled water in the humidifier.Fibrous (hair-like) contaminant found in bottom enclosure of device and on heater plate of humidifier.Dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, on the flip lid seal, and in the airpath, suggesting a source external to the device.The logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.
Event or Problem Description
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 previuosly received information alleging had to go to emergency to have throat cleared related to a cpap device's sound abatement foam.The patient has alleged to seeing particles in the device.There was no report of serious or permanent patient harm or injury.

• Brand Name: DREAMSTATION CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, pa, PA 15206 ; 2673970028
• MDR Report Key: 12809817
• Report Number: 2518422-2021-06633
• Device Sequence Number: 17514109
• Product Code: BZD
• UDI-Device Identifier: 00606959026537
• UDI-Public: 00606959026537
• 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): 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CAX200H12
• Device Catalogue Number: CAX200H12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2018
• 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
• Patient Sex: Unknown