BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 11440956 · Received March 8, 2021

    Report

    Report Number
    2031642-2021-00883
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Report Date
    September 2, 2021
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATA ACQUISITION ASSEMBLY (DAQ) WAS RECEIVED FOR FAILURE INVESTIGATION. VISUAL INSPECTION OF THE DAQ REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE DAQ WAS TESTED AND ROOT CAUSE IS FAILURE OF DAQ ASSEMBLY, CAUSED BY U7 DRIFTING OUT OF CALIBRATION.

    Additional Manufacturer Narrative · 0

    G4:29MAR2021. B4:06APR2021. H11: B5: THE CUSTOMER CALLED TECHNICAL SUPPORT (TS), REPORTING THAT THE DEVICE DISPLAYED A MACHINE PRESSURE SENSOR AUTO ZERO FAILED AND SPEAKER TEST (PM PCBA & MC PCBA) ERROR MESSAGE. 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

    G4:29MAR2021. B4:09APR2021. THE TECHNICAL SUPPORT FOUND NO PROBLEM WITH THE SPEAKER TEST. THE EQUIPMENT PASSED TESTING. 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) 2021. 08MAR2021.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED INTO TECHNICAL SUPPORT (TS) REPORTING THAT THE DEVICE¿S BATTERY FAILED ALARM AND TURNS OFF EVEN ON AC. THIS EVENT WAS REPORTED TO HAVE OCCURRED DURING CLINICAL USE. THERE WAS NO ALLEGATION OF HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS BEING SET UP WHEN THE ISSUE OCCURRED AND THAT UNIT NEVER CAME IN CONTACT WITH THE PATIENT. THE CUSTOMER USED ANOTHER V60. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN EVALUATED THE VENTILATOR AND CONFIRMED THE REPORTED PROBLEM. THE DATA ACQUISITION RP-PCBA FAILED AFTER SWITCHING ON THE EQUIPMENT. THE SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION BOARD ASSEMBLY (DA PCBA) AND THE PROBLEM WAS RESOLVED. THE DEVICE WAS PUT BACK INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327874 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1