BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 9985291 · Received April 22, 2020

    Report

    Report Number
    8010042-2020-00234
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    March 28, 2020
    Report Date
    February 9, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED MULTIPLE SELF-TESTS DURING PRE-USE CHECK (PUC). THE EVALUATION OF RECEIVED DEVICE LOGS SHOWS THAT THERE ARE 16 FAILED PUC BETWEEN (B)(6) 2019 AND (B)(6) 2020. THE DATE OF EVENT IS RETAINED. THE LAST SUCCESSFUL PUC PASSED (B)(6) 2019, 10 MONTHS BEFORE THE REPORTED EVENT. THERE ARE NO TECHNICAL ERRORS THE LAST EIGHT MONTHS. SEVERAL PUC FAILED ON THE INTERNAL LEAKAGE TEST. THE FLOW TRANSDUCER TEST ALSO FAILED FREQUENTLY AS DID THE PRESSURE TRANSDUCER TEST. THESE FAILURES MAY HAVE SEVERAL CAUSES INCLUDING PROBLEMS WITH THE GAS MODULES, PRESSURE TRANSDUCERS AND EXPIRATORY CASSETTE. IT WAS LATER REPORTED THAT THE VENTILATOR WORKED AS EXPECTED AND THAT NO PARTS HAD BEEN REPLACED. THE TRUE CAUSE OF THE REPORTED PUC FAILURES WAS NOT ESTABLISHED.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED MULTIPLE SELF-TESTS DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450081 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1