BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4110650 · Received September 16, 2014

    Report

    Report Number
    8010042-2014-00420
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED EXPIRATORY CHANNEL PC BOARD AND EVAL OF RECEIVED DEVICE LOGS HAS BEEN COMPLETED. EVAL OF RECEIVED LOGS CONFIRMS A SINGLE OCCURRENCE OF THE REPORTED TECHNICAL ERROR ON THE DATE OF EVENT. SEVERAL MEDIUM AND HIGH PRIORITY ALARMS OCCURRED IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER STATED THERE WAS NO PT INVOLVEMENT. SIMULATED USE TESTING OF THE RETURNED EXPIRATORY CHANNEL BOARD IN A REFERENCE VENTILATOR WITH A TEST LUNG FOR MORE THAN A WEEK DID NOT GIVE ANY INDICATIONS OF ANY DEVIATIONS. SEVERAL PRE-USE CHECKS PASSED WITHOUT REMARKS. TO PROVOKE THE EXPIRATORY CHANNEL BOARD TO FALL, THERMAL AND MECHANICAL STRESSES WERE APPLIED TO SELECTED COMPONENTS, WITHOUT THAT THERE WERE NO ERRATIC BEHAVIORS THAT OCCURRED. A FAILURE READING TO THE REPORTED TECHNICAL ERROR MAY LEAD TO A STOP IN VENTILATION IF THE SAFETY VALVE IS NOT IN ITS PREDETERMINED STATE. APPEARANCE OF THIS FAILURE WILL BE NOTIFIED TO THE USER BY GENERATED HIGH PRIORITY ALARMS AND THE REPORTED ERROR CODE. THE CONCLUSION IN THIS MATTER IS THAT THE REPORTED ISSUE WAS CONFIRMED IN THE RECEIVED DEVICE LOGS BUT COULD NOT BE REPRODUCED DURING THE INVESTIGATION. THE RETURNED EXPIRATORY CHANNEL PC BOARD IS FOUND TO BE WITHIN ITS SPEC.

    Additional Manufacturer Narrative · 1

    THE DEVICE LOGS WERE RECEIVED AND THEY CONFIRM THE OCCURRENCE OF THE REPORTED TECHNICAL ERROR. FURTHER INFO SURROUNDING THE EVENT HAS BEEN REQUESTED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. REF EXEMPTION #:(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ALARM INDICATING AN OPEN SAFETY VALVE. THERE WAS NOT PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572230 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1