BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT70 VENTILATOR

    MDR report key: 10112298 · Received June 2, 2020

    Report

    Report Number
    8020893-2020-00085
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    April 6, 2020
    Report Date
    June 2, 2020
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    UDI-DI
    10884521544413
    PMA / PMN Number
    K111146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE HT70 VENTILATOR WAS RETURNED TO MEDTRONIC FOR ANALYSIS. VISUAL INSPECTION OF THE BOARD REVEALED A DAMAGED U1104 CHIP OF THE SBC PCB. THE FAULT WAS ISOLATED TO THE SINGLE BOARD COMPUTER (SBC) PRINTED CIRCUIT BOARD (PCB). A NEW SBC PCB WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS AS PER MANUFACTURER SPECIFICATIONS. THE LIKELY CAUSE OF THE EVENT WAS ISOLATED TO DAMAGED U1104 CHIP IN SBC BOARD. THE EVENT WILL BE INCLUDED IN TRENDING AND MONITORING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICING, THE HT70 VENTILATOR SCREEN WAS OBSERVED TO BE FROZEN AND THE UNIT WAS LOCKED UP/ STOPPED VENTILATING. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573283 HT70 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN HT70PM-WW-NA 10884521544413

    Patients

    Seq Age Sex Outcome Treatment
    1