MAUDE Adverse Event Report: RESPORINOC INC REMSTAR AUTOA-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AU561TS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	10/30/2022
Type of Reportable Event	Malfunction
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 alleging an issue related to a cpap device's sound abatement foam became degraded and caused lung issues and a lung nodule.The patient did report to receive medical intervention and was hospitalized.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Additional information was received on nov 19, 2024, and section h10 should be reported as: 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 alleging an issue related to a cpap device's sound abatement foam became degraded and caused lung issues and a lung nodule.The patient did report to receive medical intervention and was hospitalized.No device has been returned.No further evaluation is possible at this time.A final report is being submitted.If new information becomes available that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.Section b1 was corrected for product problem.(both adverse event and product problem was checked in the previous mdr.) section b2 was corrected to blank.(previously, it was other serious or important medical events.) section h1 was changed from serious injury to malfunction.Section h6 codes captured incorrectly in previous report, it has been corrected and updated in this report.

• Brand Name: REMSTAR AUTOA-FLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPORINOC INC; 101 murry ridge lane; murrysville, pa PA 15668
• Manufacturer (Section G): RESPORINICS, INC; 1001 murry ridge lane; murrysville,pa PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittisburgh,pa, PA 15206 ; 7243512041
• MDR Report Key: 15745243
• Report Number: 2518422-2022-90076
• Device Sequence Number: 7133493
• Product Code: BZD
• UDI-Device Identifier: 00606959005488
• UDI-Public: 00606959005488
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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: AU561TS
• Device Catalogue Number: AU561TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2022
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female