BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8847082 · Received July 31, 2019

    Report

    Report Number
    8010042-2019-00562
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Report Date
    March 26, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS REPORTED WITH AN INTERNAL LEAKAGE TEST FAILED DURING PRE-USE CHECK. THE RECOMMENDATION IS TO CHANGE THE OXYGEN GAS MODULE, BUT THE HOSPITAL HAS DECIDED NOT TO REPAIR THE VENTILATOR. NO MORE INFORMATION OR LOG FILES HAVE BEEN RECEIVED. NO NEW EVENTS ON THIS VENTILATOR HAVE BEEN REPORTED UNTIL THIS DATE. AS NO GOODS WERE RETURNED FOR INVESTIGATION AND NO INFORMATION REGARDING THE SERVICE MEASURES, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REF. #: 232932.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638885 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1