BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 12412350 · Received September 2, 2021

    Report

    Report Number
    8010042-2021-02139
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 7, 2021
    Report Date
    September 2, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE DID NOT TURN ON DURING START-UP PROCEDURE. THE ISSUE HAS BEEN CONFIRMED BY ANALYZING PROBLEM DESCRIPTION AND COMMUNICATION WITH FIELD SERVICE ENGINEER (FSE). THE DEVICE¿S LOGS AND SERVICE REPORT WERE NOT AVAILABLE FOR FURTHER EVALUATION. IT HAS BEEN CLARIFIED THAT THAT THE REPORTED ISSUE HAS BEEN RELATED TO THE POWER CONTROL CIRCUIT BOARD, WHICH CONNECTS AND CONTROLS CHARGING OF THE BATTERY MODULES. THE POWER CONTROL CIRCUIT BOARD HAS BEEN REPLACED AND THE DEVICE WAS RETURNED FOR USE. THERE WERE NO FURTHER FAILURES. DEFECTIVE PART HAS NOT BEEN RETURNED FOR INVESTIGATION. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. THE CORRECTION OF FIELD #H4 DEVICE MANUFACTURE DATE WAS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. #H4 MANUFACTURE DATE: PREVIOUS MANUFACTURE DATE: 12/07/2003. CORRECTED MANUFACTURE DATE: 12/12/2003.

    Description of Event or Problem · 0

    MANUFACTURER'S REF.#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DID NOT SWITCH ON. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314177 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown