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

Model Number	FRX500S14
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a 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 received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury.In the initial report section b5 was not updated, the correct b5 should be - the patient has alleged 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 internal visual inspection was completed by the manufacturer.The manufacturer found evidence of contamination in the blower box, contamination on the back panel of the device.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found one e-4 and one e-200 on the error log.The manufacturer concludes the contaminates found were consistent with contamination in the blower box, contamination on the back panel of the device.The manufacturer confirmed there was no evidence of sound abatement foam degradation.Section d9,g3,h6 has been updated/corrected.

• Brand Name: DREAMSTATION AUTO, FR
• 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: 12625235
• Report Number: 2518422-2021-05173
• Device Sequence Number: 3451361
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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: 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: 09/20/2021
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2017
• 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