BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8227670 · Received January 8, 2019

    Report

    Report Number
    2031642-2019-00160
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    December 19, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE REC¿D BY MFR : 01MAR2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER CONFIRMED THE REPORTED TOUCHSCREEN ISSUE. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) REPLACED THE DEFECTIVE TOUCHSCREEN TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. 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

    REPORT DATE: 05/04/2019. MANUFACTURE DATE: 05/04/2019. FAILURE ANALYSIS ON THE RETURNED TOUCH SCREEN SHOWS THAT THE UL_LR AND UR_LL RESISTANCE WERE OUT OF SPEC AND RESISTANCE RATIO UL_LR/ UR_LL WERE OUT OF SPEC. 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

    EVENT DATE: (B)(6) 2018. DATE OF REPORT: 08JAN2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TOUCHSCREEN WILL NOT CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT. EVENT DATE NOT SPECIFIED; ESTIMATE USED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21247 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1