BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2964173 · Received February 11, 2013

    Report

    Report Number
    8010042-2013-00014
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION HAS SO FAR BEEN RECEIVED ON WHETHER ANY PARTS WERE EXCHANGED AND NOT ALL THE REQUESTED DEVICE LOGS HAVE BEEN RECEIVED. THE HOSPITAL HOWEVER SENT A VIEW LOG BUT THIS STARTS WITH ONGOING VENTILATION AND DOES NOT INCLUDE THE MODE OF VENTILATION OR ALL THE SET PARAMETERS AT THE TIME. FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED AFTER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DELIVERED 14 BREATHS INSTEAD OF THE SET 17 BREATHS. IT WAS ALSO STATED THAT PEEP WAS SET TO 5 BUT IT WAS READING 1. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59564 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI