BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8771527 · Received July 9, 2019

    Report

    Report Number
    8010042-2019-00466
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Report Date
    May 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

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK (PUC). THERE WAS NO PATIENT INVOLVEMENT. OUR FIELD SERVICE ENGINEER CONCLUDED THAT THE PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD (PCB) BOARD (EXPIRATORY SIDE) CAUSED THE PRE-USE CHECK FAILURES AND REPLACED THE PRESSURE TRANSDUCER PCB ACCORDING TO THE RECOMMENDATION IN THE SERVICE MANUAL. AFTER REPLACEMENT FUNCTIONAL AND SAFETY TESTS PASSED ACCORDING TO FACTORY SPECIFICATIONS. NO PART WAS RETURNED FOR INVESTIGATION. THE EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS SEVERAL CLINICAL ALARMS FOR HIGH AIRWAY PRESSURE, PEEP LOW AND HIGH RESPIRATORY RATE BEFORE (B)(6)2019 THAT MAY BE RELATED TO THE REPORTED PUC FAILURES. THE VENTILATOR WASN'T IN USE AFTER THAT OTHER THAN FOR DIFFERENT TESTS. 2 PUC FAILED (B)(6)2019 ON INTERNAL LEAKAGE AND TRANSDUCER TESTS AND ONE(B)(6)2019 ON THE PRESSURE TRANSDUCER TEST. IN ADDITION TO THESE, THERE ARE MANY SUCCESSFUL PUC. THE EVENT WAS DISCOVERED DURING PRE-USE CHECK. DURING VENTILATION, A PRESSURE TRANSDUCER MEASUREMENT FAILURE MAY LEAD TO HIGH AIRWAY PRESSURE AND GENERATION OF RELATED PRESSURE ALARMS. THE CONCLUSION IN THIS MATTER IS THAT THE PRESSURE TRANSDUCER WAS MALFUNCTIONING AND WAS REPLACED BY OUR FIELD SERVICE ENGINEER. AS NO GOODS WAS RETURNED THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 221537.

    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 REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565791 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1