BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8797376 · Received July 17, 2019

    Report

    Report Number
    8010042-2019-00500
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Report Date
    August 28, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE COMPLAINT HAS BEEN COMPLETED. IT IS BASED ON RECEIVED DEVICE LOGS AND SERVICE REPORTS FROM A FEW SERVICE VISITS BY OUR FIELD SERVICE ENGINEER. NO PART WAS RETURNED DESPITE REQUESTS. IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. AFTER CONSULTATION, OUR FIELD SERVICE ENGINEER REPLACED THE MAIN BACK-PLANE PRINTED CIRCUIT BOARD (PCB), SAFETY VALVE PULL MAGNET AND INSPIRATORY PRESSURE TRANSDUCER TUBE FILTER HOLDER WHICH RESOLVED THE FAILED PRE-USE CHECK LEAK AND PRESSURE TESTS. IN A FOLLOW-UP VISIT HE REPLACED THE AIR AND O2 GAS MODULES WHICH RESOLVED THE FAILING PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. AFTER REPAIR THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS TO FACTORY SPECIFICATIONS. NO FURTHER ISSUES HAVE BEEN REPORTED. THE EVALUATION OF THE RETURNED DEVICE LOGS SHOW SEVERAL FAILED AND CANCELLED/ABRUPTED PRE-USE CHECKS BETWEEN(B)(6)2019 AND (B)(6)2019 . MANY OF THEM HAD FAILED ON THE REPORTED LEAKAGE AND PRESSURE TRANSDUCER TESTS. THE EVENT WAS DISCOVERED DURING PRE-USE CHECK. DURING VENTILATION, CORRESPONDING ALARMS WILL BE GENERATED. THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE MAIN BACK-PLANE PRINTED CIRCUIT BOARD, PULL MAGNET, FILTER HOLDER, AIR GAS MODULE AND O2 GAS MODULE. AS NO GOODS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF.: 221585.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591734 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1