BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 2111030 · Received April 15, 2011

    Report

    Report Number
    8010042-2011-00056
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K041223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST, THE PRESSURE TRANSDUCER TEST AND THE SAFETY VALVE TEST DURING PRE-USE CHECK. IT WAS ALSO REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ALARM, INDICATING STOP OF VENTILATION DUE TO COMMUNICATION FAILURE BETWEEN THE CONTROL PRINTED CIRCUIT BOARD AND THE MONITORING PRINTED CIRCUIT BOARD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-S CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1