BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8846165 · Received July 31, 2019

    Report

    Report Number
    2031642-2019-05277
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Report Date
    July 18, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 31JULY2019. THE AC POWER CORD (POWER CORD,3 WIRE,RT ANGLE,NA,10A)WAS RETURNED TO THE FI (FAILURE INVESTIGATION) LAB FOR EVALUATION. NO OBVIOUS WEAR, DAMAGE OR CUTS ALONG MAIN CONDUCTOR INSULATION. INSPECTION OF MAIN CORD INSULATOR TO BOTH PLUG END STRAIN RELIEFS REVEALED SEPARATION OF INSULATOR FROM WALL PLUG INSIDE DIAMETER. THE CUSTOMER REPLACED THE DEFECTIVE AC POWER CORD TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. VERIFIED REPORTED FAILURE OF ESA RESISTANCE OUT OF SPECIFICATION. VERIFIED GND-GND RESISTANCE OUT OF SPECIFICATION. NOTED RESISTANCE OF 775KOHMS BETWEEN GND-L. ROOT CAUSE DETERMINED TO BE MECHANICAL DAMAGE OF CABLE AT WALL PLUG END.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNIT FAILED ELECTRICAL TEST, POWER CORD RESISTANCE AND FAILED THE (PREVENTATIVE MAINTENANCE) PM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638682 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1