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

Model Number	CAX501H12
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a respiratory infection.The patient was hospitalized in response to the reported event.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 received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a respiratory infection.The patient was hospitalized in response to the reported event.Upon further review, the reported events of hospitalization due to respiratory infection and blisters in her mouth; was given with antibiotics, iv, and oxygen and the patient stated a green medication is for rinsing her mouth were assessed as non serious injury.The device was returned to the manufacturer product investigation lab for further evaluation.The external aspect of the device was inspected and the manufacturer observed there was unknown dust/dirt contamination present on all surfaces of the base unit.The device did not return with an sd card or filter.There was an unknown dust contamination present at the air inlet of the filter and at the iso port entrance.The internal aspect of the device was inspected and the manufacturer observed unknown debris in the tracks of the ui panel.The manufacturer found that there were mineral deposits present on the motor casing and blower box housing suggesting unknown liquid ingress.There was an unknown white dust contamination found on the bottom enclosure, blower box housing, blower motor, blower impeller, and rear panel o-ring.Evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The manufacturer confirmed no presence of degraded sound abatement foam.Section b1 has been corrected to reflect product problem and section h1 has been updated to reflect malfunction in this report.Section d8, d9, h2 and h3 has been updated.Section h6 health effect - impact code, medical device problem code, type of investigation, investigation findings, investigation conclusions have been updated in this report.

• Brand Name: DREAMSTATION EXPERT
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13305783
• Report Number: 2518422-2022-01333
• Device Sequence Number: 19669596
• Product Code: BZD
• UDI-Device Identifier: 00606959053168
• UDI-Public: 00606959053168
• 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): 12/07/2023

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: CAX501H12
• Device Catalogue Number: CAX501H12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• 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