BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8289889 · Received January 30, 2019

    Report

    Report Number
    2031642-2019-00613
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Report Date
    January 9, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT : 21JUN2019, DATE REC¿D BY MFR : 03MAR2019. THE DATA ACQUISITION BOARD PRINTED CIRCUIT ASSEMBLY (DAQ) WAS RETURNED TO THE MANUFACTURER'S FAILURE INVESTIGATION LAB FOR EVALUATION. VISUAL INSPECTION OF THE DAQ REVEALED NO SIGNS OF PHYSICAL DAMAGE AND CONTAMINATION. THE DAQ WAS 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 DAQ PASSED ALL TESTING, AND NO ERRORS WERE GENERATED. THE REPORTED COMPLAINT OF A VENTILATOR WITH A MACHINE PRESSURE SENSOR AUTO ZERO FAILURE (ERROR CODE 1108) WAS NOT DUPLICATED, NO FAULT WAS FOUND ON THE RETURNED DAQ. 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: 30JAN2019. (B)(4). THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN COULD NOT CONFIRM THE REPORTED ISSUE. HOWEVER, AN ERROR CODE INDICATING "MACHINE PRESSURE SENSOR AUTOZERO FAILED" WAS FOUND IN THE DEVICE LOGS. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY TO ADDRESS THE REPORTED PROBLEM. THE UNIT WAS CHECKED OVERALL, RUN IN TESTED, CLEANED AND FUNCTIONALLY TESTED AND NO ABNORMALITY WAS CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CHECK VENT ALARM OCCURRED DURING AN IN-HOUSE RUN TEST. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT DATE WAS NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81005 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1