BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8955890 · Received September 3, 2019

    Report

    Report Number
    8010042-2019-00658
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    July 9, 2019
    Report Date
    May 25, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR DIDN'T WORK AT ALL WHEN SWITCHING ON THE UNIT. THE PLUG & PLAY BACK-PLANE PRINTED CIRCUIT BOARD (PCB) WAS CONSIDERED TO BE THE CAUSE AND IT WAS REPLACED BY OUR FIELD SERVICE ENGINEER. AFTER REPLACEMENT, A PRE-USE CHECK PASSED BUT SUDDENLY A TECHNICAL ERROR INDICATING A POWER ERROR APPEARED. AFTER CONSULTATION, THE MONITORING PCB WAS ALSO REPLACED WHICH SOLVED THE REMAINING PROBLEMS. NO PART HAS BEEN RETURNED FOR INVESTIGATION DESPITE REQUESTS. NO FURTHER ISSUES HAVE BEEN REPORTED. THE EVALUATION OF THE RECEIVED DEVICE LOGS CONFIRMS THE REPORTED POWER ERROR ON THE AWARE DATE (B)(6)2019 WHEN THE VENTILATOR WAS INVESTIGATED/SERVICED. THE EVENT LOG ONLY CONTAIN ENTRIES FROM THIS DAY. NO LOG ENTRIES APPEARED BETWEEN(B)(6)2019 AND (B)(6)2019 INDICATING THAT THE VENTILATOR HAD NOT BEEN IN USE FOR A 6 WEEK PERIOD. (B)(6)2019 THERE WERE TECHNICAL ERRORS INDICATING POWER AND COMMUNICATION PROBLEMS IN THE TECHNICAL LOG. (B)(6)2019 , BEFORE THE BREAK IN USE, THERE WERE TECHNICAL ERRORS INDICATING POWER, COMMUNICATION AND BAROMETER PROBLEMS. THESE ERRORS MAY HAVE SEVERAL CAUSES, BUT THE REPLACED PCBS ARE A COMMON DENOMINATOR. BASED ON THIS INFORMATION, THE DATE OF EVENT WILL BE SET TO (B)(6)2019 . THE CONCLUSION IN THIS MATTER IS THAT THE REPORTED TECHNICAL ERROR COULD BE CONFIRMED IN THE RECEIVED DEVICE LOGS AND THAT REPLACING THE PLUG & PLAY BACK-PLANE PCB AND MONITORING PCB RESOLVED THE REPORTED PROBLEMS. AS NO GOODS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 242765.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A POWER ERROR. THERE WAS NO PATIENT HARM. MANUFACTURER REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748736 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1