BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11681565 · Received April 16, 2021

    Report

    Report Number
    2031642-2021-03397
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 17, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS TO RETRIEVE DEVICE REPAIR OR DIAGNOSTIC INFORMATION HAS YIELDED NO RESPONSE FROM THE CUSTOMER. IT IS UNKNOWN IF ANY PARTS OR REPAIR HAS BEEN CONDUCTED. THE COMPLAINT WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE RESPIRATORY THERAPIST REPORTED THE UNIT GAVE A "PROXIMAL ALARM." THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON A PATIENT. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND REQUESTED SERVICE REPAIR. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578412 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown