BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10417590 · Received August 17, 2020

    Report

    Report Number
    2031642-2020-02801
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Report Date
    July 24, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 27OCT2020. B4: 09NOV2020. THE FIELD SERVICE ENGINEER REPLACED THE DAQ PCBA (DATA ACQUISITION PRINTED CIRCUIT BOARD ASSEMBLY) AND THE REPORTED PROBLEM WAS RESOLVED. A DAQ (DATA ACQUISITION) WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION OF THE RETURNED COMPONENT WAS PERFORMED, NO NOTABLE CONDITIONS WERE FOUND. THE RETURNED COMPONENT WAS INSTALLED INTO A TEST VENTILATOR FOR ANALYSIS. AN INVESTIGATION WAS PERFORMED AND THE PRODUCT ANALYSIS TECHNICIAN REPORTED THAT NO FAILURES WERE FOUND WITH THE RETURNED COMPONENT. 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

    G4: 22OCT2020. B4: 28OCT2020. THE FSE (FIELD SERVICE ENGINEER) EVALUATED THE DEVICE AND FOUND THAT ONE OF THE PINS ON THE DAQ (DATA ACQUISITION BOARD, PRINTED CIRCUIT BOARD ASSEMBLY) AND SOLENOID WERE NOT ALIGNED PROPERLY. THE FSE REMOVED THE DAQ AND RE-SEATED ALL THE SOLENOID PINS TO THE DA PCB CONNECTOR PROPERLY. 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) 2020. DATE OF REPORT: 17AUG2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CHECK VENTILATOR ALARM RELATED TO A PRESSURE TRANSDUCER FAILURE AND A MACHINE PRESSURE SENSOR RANGE ERROR. THE DEVICE WAS IN CLINICAL USE, BUT THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876313 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER