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

Model Number	561CA
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Nausea (1970); Vomiting (2144); Cough (4457); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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Event or Problem Description
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 received information from the patient alleging that the patient has throat trouble, nose irritation, persistent cough, shortness of breath, headache, nausea, vomiting.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection of the device was completed by the manufacturer and found no contamination.An internal visual inspection of the device was completed by the manufacturer and found dust contamination on the pca, on the top of the blower box.The manufacturer also received a humidifier with the device.An internal visual inspection of the humidifier was completed by the manufacturer and found contamination on bottom enclosure of the humidifier, on the humidifier lid seal.Mineral deposits in the water tank.Contamination on blower box and on pca.The manufacturer found there was no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found 0 errors.The device was applied power and the device operated properly.The manufacturer concludes contamination of dust found were external to the device and mineral deposit consistent with water tank.The manufacturer concludes there was no evidence of sound abatement foam degradation.

• Brand Name: REMSTAR AUTO A-FLEX
• 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 15208 ; 4125423300
• MDR Report Key: 18037713
• Report Number: 2518422-2023-28227
• Device Sequence Number: 7429081
• Product Code: BZD
• UDI-Device Identifier: 00606959030527
• UDI-Public: 00606959030527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial

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: 561CA
• Device Catalogue Number: 561CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown