BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3983219 · Received July 3, 2014

    Report

    Report Number
    8010042-2014-00294
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    ON-SITE INVESTIGATION SHOWED THAT THE REPORTED PROBLEM WAS CORRECTED BY REPLACING THE MAIN BACK-PLANE PRINTED CIRCUIT BOARD. THE MAIN BACK-PLANE IS AN INTER-CONNECTION BOARD FOR THE PRINTED CIRCUIT BOARDS IN THE LOWER PART OF THE VENTILATOR. THE REPLACED PART BELONGS TO THE CUSTOMER, AND HAS NOT BEEN RETURNED FOR INVESTIGATION DESPITE OUR REQUESTS. RECEIVED DEVICE LOGS SHOWED THAT THE PERFORMED PRE-USE CHECKS HAD FAILED IN SEVERAL SUB-TESTS. DUE TO LACK OF THE REPLACED PART, THE TRUE CAUSE OF IT'S FAILURE HAS NOT BEEN DETERMINED. ACCORDING TO RECEIVED INFORMATION THE REPORTED VENTILATOR WAS RETURNED TO SERVICE WITH NO MORE FAILURES HAVING SEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392343 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1