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 Codes	Asthma (1726); Cough (4457); Unspecified Respiratory Problem (4464)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused the patient to have asthma.The medical intervention that the patient received in response to the event is currently unknown.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 became degraded and caused the patient to have asthma.The medical intervention that the patient received in response to the event is currently unknown.In this initial report section b5 was incorrect, the correct b5 should be - the patient has alleged asthma, cough and stuffy nose.The relationship between the device and the symptoms is currently unclear.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of device was completed by the manufacturer and found evidence of dust/dirt contamination on the air inlet, iso port, top/bottom cover, motor casing/impellers, rear panel, and blower box, contamination throughout the airpath, mineral spots with water ingress within the blower box and on the motor casing, 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 device was applied power and the device operated properly.The manufacturer concludes the contaminates found were consistent with dust/dirt contamination on the air inlet, iso port, top/bottom cover, motor casing/impellers, rear panel, and blower box, contamination throughout the airpath, mineral spots with water ingress within the blower box and on the motor casing, black contamination at the blower seal of the blower box, keratin contamination.The manufacturer confirmed there was no evidence of sound abatement foam degradation.In this report, section d9, g3, h6 have been updated/corrected.

• Brand Name: DREAMSTATION AUTO BIPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• 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: 13077803
• Report Number: 2518422-2021-08549
• Device Sequence Number: 6010457
• 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): 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): 08/10/2023

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: 10/19/2021
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2016
• 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