BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11735227 · Received April 27, 2021

    Report

    Report Number
    2031642-2021-03446
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 29, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838009851
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS TO RETRIEVE DEVICE REPAIR, AND OPERATIONAL STATUS HAS YIELDED NO RESPONSE. IT IS UNKNOWN IF ANY PART WAS REPLACED OR IF REPAIR HAS BEEN CONDUCTED. THE COMPLAINT WILL BE PROCESSED FOR CLOSURE. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INSTITUTION: (B)(6). POSTAL CODE: (B)(6). CUSTOMER PHONE #: (B)(6).

    Description of Event or Problem · 1

    PROBLEM STATEMENT: THE CUSTOMER REPORTED THAT THE DEVICE DOESN'T TURNED ON. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND ADVISED THAT IT IS POSSIBLE THAT A FAULTY BATTERY IS BLOCKING THE DEVICE FROM TURNING ON. IT IS NECESSARY TO DISCONNECT THE "NATIVE" BATTERY OF THE DEVICE AND TRY TO TURN ON THE DEVICE. IF IT DOESN'T HELP, THEN CHANGE THE PM, AND THEN THE POWER SUPPLY, THEN THE CPU. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628879 RESPIRONICS V60 VENTILATOR WITH PPV AND AUTO-TRAK+SOFTWARE OPTIONS MNT RESPIRONICS CALIFORNIA, LLC V60 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown