BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMUSRS

    MDR report key: 7405254 · Received April 6, 2018

    Report

    Report Number
    1119903-2018-00001
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    March 1, 2018
    Report Date
    March 7, 2018
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    ISD
    PMA / PMN Number
    K933611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OCCUPATIONAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT COMMUNICATION LOGS MATCH THE SCENARIO AND TIMELINE DESCRIBED BY THE CUSTOMER AND INDICATE THAT USER ERROR CAUSED THE INCIDENT. THE THERAPIST SET VERY LOW RESISTANCE FORCES THAT WERE UNDER 1 LB. HOWEVER, THE THERAPIST WAS PROBABLY EXPECTING A MUCH HIGHER RESISTANCE WHEN USING THE SYSTEM. HE FELL BECAUSE THERE WAS NO RESISTANCE ON THE CABLE DUE TO HIS DATA ENTRY ERROR. THE EQUIPMENT IS CAPABLE TO PROVIDE UP TO 140 LBS. RESISTANCE WHILE TOOL 191 IS UTILIZED.

    Description of Event or Problem · 1

    PHYSICAL/OCCUPATIONAL THERAPIST THAT OPERATED THE DEVICE WAS DEMONSTRATING A PULL EXERCISE. HE INTENDED TO WALK BACKWARDS WHILE PULLING TOOL 191 CABLE. HE PULLED ON THE CABLE AND LOST HIS BALANCE DUE TO NO RESISTANCE. HE FELL AND IS AWAITING AUTHORIZATION FOR PHYSICAL THERAPY FOR LOWER BACK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246248 PRIMUSRS PRIMUS ISD BTE TECHNOLOGIES, INC. PRIMUSRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other