BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 9997943 · Received April 24, 2020

    Report

    Report Number
    2031642-2020-01535
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Report Date
    April 7, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 04AUG2020. B4: 05AUG2020. THE TOUCHSCREEN ASSEMBLY WAS RETURNED TO THE MANUFACTURER'S FAILURE INVESTIGATION LAB FOR EVALUATION. VISUAL INSPECTION OF THE TOUCHSCREEN ASSEMBLY REVEALED NO SCRATCHING OR OTHER DAMAGE. PIN TO PIN RESISTANCE TESTING FAILED FROM PIN 1 (UL Y) TO PIN 4 (LR X). THE TOUCHSCREEN ASSEMBLY WAS THEN INSTALLED INTO THE FI TEST VENTILATOR TO VERIFY & TEST ITS FUNCTIONAL INTEGRITY. FROM TESTING, IT WAS DETERMINED THAT THE TEST VENTILATOR UTILIZED WITH THE RETURNED TOUCHSCREEN ASSEMBLY FAILED CALIBRATION TESTING. THE BUTTONS AT THE BOTTOM EDGE OF THE SCREEN DID NOT RESPOND PROPERLY. THE REPORTED EVENT WAS VERIFIED. RESISTANCE MEASUREMENT FAILED TO TEST, AND CALIBRATION OF THE TOUCHSCREEN ASSEMBLY DID NOT PERFORM CORRECTLY. THE TOUCHSCREEN WAS FOUND TO FAIL SPECIFICATIONS. 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 · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 24APR2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TOUCH PANEL DOESN'T RESPOND. THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE RIGHT UPPER PART ON THE TOUCH PANEL DIDN'T RESPOND. THE FSE REPLACED THE TOUCHSCREEN TO ADDRESS THE REPORTED PROBLEM. THE UNIT WAS CHECKED OVERALL, RUN IN TESTED, CLEANED AND FUNCTIONALLY TESTED AND NO ABNORMALITY WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462558 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1