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 Codes	Cough (4457); Nodule (4551)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
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 lung stain.There is no report of the medical intervention that the patient has received at this time.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 a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a lung stain.There is no report of the medical intervention that the patient has received at this time.In the initial report section b5 was not updated, the correct b5 should be - the patient has alleged cough, mucus and lung stain.There was no report of the medical intervention required by the patient.In the initial report, section h10 was marked incorrectly.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 slight black contamination at the blower seal of the blower box, keratin contamination, white and black unknown contamination (dust like) and some very small potential hairs at the air input of the blower box.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found 3 instances of e-53, 17 instances of e-105, 1 instance of e-250 and 3 instances of e-130 on the error log.The manufacturer concludes the contaminates found were consistent with slight black contamination at the blower seal of the blower box, keratin contamination and white and black unknown contamination (dust like) and some very small potential hairs at the air input of the blower box inconsistent with the sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation.

• 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: 12676504
• Report Number: 2518422-2021-05648
• Device Sequence Number: 1231973
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2022

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: 10/18/2021
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female