BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOPRONE

    MDR report key: 3930034 · Received March 10, 2014

    Report

    Report Number
    3010048749-2014-00009
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BY THE MANUFACTURER ARJOHUNTLEIGH, INC. ((B)(4)). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MANUFACTURING SITE KINETIC CONCEPTS, INC. ((B)(4)). AS OF (B)(4) 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. AND REGISTRATION # (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER INVESTIGATION. THE SUBMISSION OF THIS REPORT AND RELATED INFORMATION DOES NOT NECESSARILY REFLECT A CONCLUSION BY ARJOHUNTLEIGH THAT THE REPORT OR INFORMATION IS AN ACKNOWLEDGEMENT THAT ARJOHUNTLEIGH, ARJOHUNTLEIGH EMPLOYEES OR ARJOHUNTLEIGH PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE. THE ROTOPRONE HAD A CONTROL ERROR ALARM ON THE SCREEN AND STOPPED ROTATING. THE CONTROL ERROR ALARM BEGAN AFTER THE PATIENT HAD BEEN ROTATING FOR SEVERAL HOURS IN THE PRONE POSITION. THE ARJOHUHTLIEGH CLINICAL SPECIALIST VERBALLY INSTRUCTED THE NURSE TO MANUALLY PLACE THE PATIENT IN THE SUPINE POSITION, UNPLUG THE UNIT, RE-SET THE BATTERY SWITCH WHICH RESOLVED THE ALARM. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143801 ROTOPRONE IKZ ARJOHUNTLEIGH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1