BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3192596 · Received June 20, 2013

    Report

    Report Number
    8010042-2013-00097
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL BIOMED NO FAULT WAS FOUND AND NO PARTS WERE REPLACED. CONSEQUENTLY THE VENTILATOR WAS RETURNED TO SERVICE. OUR FIELD SERVICE ENGINEER WHO WAS DISPATCHED TO THE FACILITY AFTER RECEIPT OF THE (B)(4) MEDWATCH REPORT FOUND THE VENTILATOR IN SERVICE BUT DOWNLOADED THE DEVICE LOGS. THE EVENT LOG THAT CONTAINS INFORMATION SUCH AS PARAMETER SETTINGS, SET ALARM LIMITS AND GENERATED PATIENT RELATED ALARMS DID NOT COVER THE EVENT DATE. DUE TO CONTINUED USE OF THE VENTILATOR THE EVENT LOG FOR EVENT DATE HAD BEEN OVERWRITTEN. THE TEST LOG THAT CONTAINS THE RESULTS OF ALL TESTS PERFORMED DURING THE AUTOMATED PRE-USE CHECK SHOWED THAT THE LAST SUCCESSFUL PRE-USE CHECK WAS PERFORMED 28 DAYS BEFORE THE EVENT. THE TEST LOG FURTHER SHOWS THAT THE PRE-USE CHECK PERFORMED 4 DAYS AFTER THE EVENT WAS SUCCESSFUL. THE TECHNICAL LOG CONTAINS TECHNICAL ALARMS AND INFORMATION THAT WOULD INDICATE A VENTILATOR FAILURE HAS NO ENTRY ON THE EVENT DATE. THE CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED. REFERENCE EXEMPTION NUMBER: (B)(4).

    Description of Event or Problem · 1

    REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281506 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1