BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS, BTE WS30

    MDR report key: 3074880 · Received April 19, 2013

    Report

    Report Number
    1119903-2013-00002
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    ISD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER NORMAL BTE SVC PROCESS, REPLACEMENT PARTS WERE PROVIDED TO THE CLINIC. HOWEVER, PARTS FROM THE CUSTOMER SITE HAVE NOT BEEN RETURNED YET TO BTE. IT HAS BEEN VERIFIED THAT THE PARTS ARE IN TRANSIT. THE PT DATA WILL BE AVAILABLE ONCE PARTS FROM THE CUSTOMER SITE ARE REC'D AT BTE. THE PT IS AN ADULT.

    Description of Event or Problem · 1

    THE OPERATOR WAS PERFORMING A CONTINUOUS PASSIVE MOTION (CPM) TEST ON A PT'S WRIST. THE PT'S HAND WAS STRAPPED TO THE SYS ATTACHMENT (TOOL) WITH VELCRO IN ACCORDANCE WITH THE OPERATING INSTRUCTIONS. ON ONE OF THE REPETITIONS THE PRIMUS TRAVELLED PAST THE DESIRED RANGE OF MOTION BENDING THE PT'S WRIST UPWARD. AT THIS TIME A MESSAGE WAS DISPLAYED INDICATING A COMMUNICATION ISSUE WITH THE PRIMUS. THE PT WAS ABLE TO UNDO THE STRAPS AND PULL THEIR ARMS OUT OF THE ARM REST. THE CLINICIAN THEN UNPLUGGED THE MACHINE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170568 PRIMUS, BTE WS30 ISD BTE TECHNOLOGIES, INC. PRIMUSRS

    Patients

    Seq Age Sex Outcome Treatment
    1