BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 11249339 · Received January 29, 2021

    Report

    Report Number
    2031642-2021-00359
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Report Date
    January 17, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 02FEB2021. B4: 10FEB2021. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) PERFORMED A TEST RUN, BUT THE REPORTED ISSUE WAS NOT DUPLICATED. THE DRPT (DIAGNOSTIC LOG) REVEALED AN ERROR CODE CONSISTENT WITH PROXIMAL PRESSURE SENSOR AUTO ZERO FAILED HAD OCCURRED, SO THE DATA ACQUISITION BOARD WAS REPLACED. NO OTHER ABNORMALITY WAS CONFIRMED. THE SOFTWARE VERSION WAS CHECKED, AND THE UNIT WAS CLEANED AND FUNCTIONALLY TESTED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    THE DATA ACQUISITION (DAQ) BOARD ASSEMBLY WAS RETURNED FOR FAILURE INVESTIGATION (FI). THE DAQ BOARD WAS TESTED, AND NO FAULT WAS FOUND. FI TECHNICIAN COULD NOT REPLICATE THE PROBLEM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2021. DATE OF REPORT: 28JAN2021.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN OPERATIONAL CHECK WAS PERFORMED IN THE SALES OFFICE, PROXIMAL PRESSURE SENSOR AUTO-ZERO FAILED ALARM OCCURRED. THE DEVICE DID NOT HAVE PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED, THEREFORE, THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145683 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown