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	Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2021
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 the patient to have throat and nasal allergies.The patient did receive medical intervention in the form of prescription for steroids.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 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 received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have throat and nasal allergies.The patient did receive medical intervention in the form of prescription for steroids.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection was performed by the manufacturer.The manufacturer found signs of minor wear and tear.An internal visual inspection was completed by the manufacturer.The manufacturer found dust and dirt contamination on the interior of the enclosure as well as throughout the airpath.The manufacturer also observed very fine dirt particles and fibers in the blower box, particularly on the top of the blower assembly.The device's downloaded event log was reviewed by the manufacturer and found no error.The manufacturer concludes no evidence of sound abatement foam degradation or breakdown.The manufacturer confirmed the presence of fine dust contamination and multiple unknown contaminants throughout the airpath which suggests the likely source of contamination as exterior to the device.In the initial report clinical code was mentioned incorrectly which has been updated in this report.

• 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: 12631596
• Report Number: 2518422-2021-04964
• Device Sequence Number: 3421896
• 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,Company Representative
• 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: 10/04/2021
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2016
• 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: Required Intervention
• Patient Sex: Unknown