BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 15644228 · Received October 20, 2022

    Report

    Report Number
    2031642-2022-02594
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 11, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DETAILS WERE PROVIDED FROM THE REMOTE SERVICE ENGINEER (RSE), AND FIELD SERVICE ENGINEER (FSE) REGARDING THE EVALUATION OF THE DEVICE. DURING FOLLOW UP WITH THE KEY MARKET (KM), IT WAS REPORTED THAT THE HOSPITAL'S INTERNAL OXYGEN SYSTEM WAS RE-ADJUSTED TO RESOLVE THE ISSUE. IT WAS THEN REPORTED THAT THE DEVICE WAS RETURNED TO USE WITHOUT REQUIRING ANY REPLACEMENT PARTS.

    Additional Manufacturer Narrative · 0

    INSTITUTION AND REPORTER NUMBER: (B)(6).

    Description of Event or Problem · 0

    WHILE IN USE THE DEVICE HAD INTERMITTENT ALERT THAT THERE IS NO OXYGEN SUPPLY. NO REPORTS OF PATIENT OR USER HARM/INJURY. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648638 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown