MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION AUTO BIPAP/HUM/HT/CELL,CAN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CAX700T12C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a bilevel positive airway pressure (bipap) 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 received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam.There was no report of patient harm or injury.In the initial report, section h10 was marked incorrectly and b5 was incorrect, the correct b5 should be- 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 bipap device's sound abatement foam.The patient has alleged seeing particles in the device.There was no report of patient harm or injury.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 dust/dirt contamination inconsistent with degraded sound abatement foam throughout the device enclosure, and airpath, slight black contamination at the blower seal of the blower box, keratin contamination.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer concludes the contaminates found were consistent with black contamination at the blower seal of the blower box, keratin contamination and dust/dirt contamination was inconsistent with degraded sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION AUTO BIPAP/HUM/HT/CELL,CAN
• 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: 12474444
• Report Number: 2518422-2021-04037
• Device Sequence Number: 11707285
• Product Code: BZD
• UDI-Device Identifier: 00606959034600
• UDI-Public: 00606959034600
• 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
• Report Date (Section B): 06/16/2023

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: CAX700T12C
• Device Catalogue Number: CAX700T12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2019
• 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: Male