BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 24632498 · Received March 18, 2026

    Report

    Report Number
    2518422-2026-009675
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 18, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005006
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2026 18:33:38 EST (PLXS_PRD_DBM) * REF. NOTIFICATION: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695049 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS550HS 00606959005006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown