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

Model Number	FRX500S14
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have pneumonia.The patient was reportedly 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 previously received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have pneumonia.The patient was reportedly hospitalized in response to the reported event.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer.The manufacturer found evidence of white and black unknown contamination (dust like), inconsistent with degraded sound abatement foam, and some very small potential hairs at the air input of the blower box, black contamination at the air outlet of the blower box which is consistent with keratin, white and black unknown contamination (dust like) on the bottom of the blower box which is inconsistent with degraded sound abatement foam, gray (dust-like) unknown contamination inside the blower motor.The manufacturer found no evidence of sound abatement foam degradation/breakdown.The device's event logs were downloaded and reviewed.The manufacturer found no errors logged.The manufacturer concludes the very small potential hairs at the air input of the blower box and black contaminates found at the air outlet were consistent with keratin, white and black dust like contamination were inconsistent with degraded sound abatement foam, gray (dust-like) unknown contamination inside the blower motor.The manufacturer confirmed there was no evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION AUTO
• 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: 12864869
• Report Number: 2518422-2021-07234
• Device Sequence Number: 17249634
• Product Code: BZD
• UDI-Device Identifier: 00606959043060
• UDI-Public: 00606959043060
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/22/2022

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: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2018
• 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: Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male