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

Model Number	565P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aspiration Pneumonitis (4455)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
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 inflamed lungs.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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 inflamed lungs.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Despite three gfe attempts on 05/24/2023, 03/06/2025, 03/12/2025 the device has not yet been returned to the manufacturer for evaluation.There has been no response from the customer on the return of the device.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In addition, appropriate code updated/corrected in this follow-up report.

• Brand Name: REMSTAR AUTO A-FLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17416010
• Report Number: 2518422-2023-17388
• Device Sequence Number: 7182100
• Product Code: BZD
• UDI-Device Identifier: 00606959037915
• UDI-Public: 00606959037915
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 565P
• Device Catalogue Number: 565P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown