BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITOR 18 V DC POWER ADAPTER

    MDR report key: 3871272 · Received April 15, 2014

    Report

    Report Number
    3006697299-2014-00020
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 20, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE WAS BEING USED BUT THE ADAPTER STOPPED WORKING. THERE WAS NO PT INJURY OR DELAY IN SURGERY. ADDITIONAL INFO WAS REQUESTED AND ON (B)(6) 2014 ,THE FOLLOWING WAS PROVIDED BY THE BIOMEDICAL TECHNICIAN: THE PRODUCT PROBLEM WAS DISCOVERED BY A NURSE IN THE SURGICAL INTENSIVE CARE UNIT. THE BIOMEDICAL TECHNICIAN RECEIVED THE CAMINO MONITOR WITH AN UNSIGNED NOTE SAYING THE CAMINO STOPPED WORKING. THE BIOMEDICAL TECHNICIAN THEN DISCOVERED THAT THE POWER ADAPTER HAD NO OUTPUT. THE DATE OF INCIDENT WAS BELIEVED TO HAVE OCCURRED AROUND ON (B)(6) 2014. IT WAS REPORTED THAT THERE WAS NO PT HARM. NO OTHER FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230568 MONITOR 18 V DC POWER ADAPTER ACCESSORIES-CAMINO GWM INTEGRA LIFESCIENCES IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1