BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8621635 · Received May 17, 2019

    Report

    Report Number
    2031642-2019-03060
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    April 30, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT: 18JUN2019. DATE REC'D BY MFR: 17JUN2019. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED ISSUE. FSE WAS ABLE TO VERIFY TOUCHSCREEN DID NOT RESPOND TO TOUCH. 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

    MFR RECEIVED DATE: 29 AUG 2019. DATE OF REPORT RECEIVED: 30 AUG 2019. 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. THE TOUCH SCREEN ASSEMBLY WAS RETURNED TO FAILURE INVESTIGATION FOR EVALUATION. VISUAL INSPECTION OF THE TOUCHSCREEN ASSEMBLY REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. RESISTANCE MEASUREMENTS WILL BE PERFORMED ON THE RETURNED TOUCHSCREEN ASSEMBLY. THE TOUCHSCREEN MEASURED RESISTANCE AND RESISTANCE RATIOS WERE OUT OF SPECIFICATION. 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) 2019. DATE OF REPORT: 17MAY2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNIT WILL NOT CALIBRATE. THE DEVICE WAS NOT IN USE AT THE TIME OF THE REPORTED EVENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415354 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1