BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8236058 · Received January 10, 2019

    Report

    Report Number
    2031642-2019-00239
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Report Date
    November 26, 2018
    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 : 20JUN2019, DATE REC¿D BY MFR :11FEB2019. THE DATA ACQUISITION PRINTED CIRCUIT BOARD ASSEMBLY (DAQ) WAS RETURNED TO THE MANUFACTURER'S FAILURE INVESTIGATION LAB FOR EVALUATION. VISUAL INSPECTION OF THE DAQ REVEALED NO ANOMALIES. 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 THE FAILED MACHINE PRESSURE ACCURACY TEST 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

    EVENT DATE: (B)(6) 2018. DATE OF REPORT: 10JAN2019. INTERNATIONAL UDI: (B)(4). THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED PRESSURE ISSUE. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) 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

    DURING PERIODIC MAINTENANCE, THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPORTED THE DEVICE FAILED THE PRESSURE ACCURACY TEST (PVT TEST 4) AT THE 1CMH2O SETTING. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT DATE WAS NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25995 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1