BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8404669 · Received March 8, 2019

    Report

    Report Number
    2031642-2019-01363
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Report Date
    February 13, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 08MARCH2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) PERFORMED REMOTE TROUBLESHOOTING WITH THE CUSTOMER. THE FSE ADVISED THE CUSTOMER TO REPLACE THE POWER MANAGEMENT BOARD. THE CUSTOMER REPORTED THAT REPLACEMENT OF THE MOTOR CONTROLLER BOARD ULTIMATELY RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DECLARED MULTIPLE ERRORS [3.3 VOLT SUPPLY FAILED (1117), MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) ANALOG TO DIGITAL CONVERTER (ADC) FAILED (111D), OVER VOLTAGE PROTECTION CIRCUIT FAILED (1127), 5 VOLT SUPPLY FAILED (1118), 35 VOLT FAILURE (111B)]. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT DATE WAS NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196110 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1