BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8767212 · Received July 8, 2019

    Report

    Report Number
    8010042-2019-00457
    Event Type
    Malfunction
    Date Received
    July 8, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE COMPLAINT HAS BEEN COMPLETED. IT IS BASED ON THE SERVICE REPORT. NO DEVICE LOGS WERE RECEIVED AND NO PART WAS RETURNED. IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. OUR FIELD SERVICE ENGINEER CONFIRMED THAT THE PRESSURE TRANSDUCER TEST FAILED AND FOUND THAT THAT THE PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD (PCB) WAS DEFECTIVE. NO FURTHER INFORMATION HAS BEEN RECEIVED AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE REPORTED EVENT WAS DISCOVERED DURING PRE-USE CHECK. DURING VENTILATION, A PRESSURE TRANSDUCER FAILURE MAY LEAD TO HIGH AIRWAY PRESSURE AND GENERATION OF RELATED PRESSURE ALARMS. THE CONCLUSION IN THIS MATTER IS THAT THE PRESSURE TRANSDUCER PCB WAS DEFECTIVE. AS NO GOODS WAS RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REF. #: 221347.

    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
    563096 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1