BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLEX-S CPM PKG

    MDR report key: 1181037 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00271
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ORMED
    Product Code
    BXB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT WANT TO RETURN THE DEVICE, BECAUSE THE DEVICE HAD BEEN REPAIRED BY A LOCAL TECHNICIAN.

    Description of Event or Problem · 1

    SHOULDER CPM PURCHASED APPROX 2002-2003. THIS UNIT WAS SOLD AS DEMO MODEL 2035R. UNIT IS A RENTAL UNIT SENT TO THE PATIENT'S HOME FOR USE AFTER SURGERY FOR A ROTATOR CUFF INJURY. THE PATIENT WAS IN THE CHAIR BEING ATTENDED BY A RELATIVE WHEN THE ARM OF THE CHAIR, WHERE IT IS ATTACHED TO THE SHOULDER MOTOR, SLID OFF. THERE WAS A PROBLEM WITH THE WELDING. THE PERSON (RELATIVE) ATTENDING THE PATIENT, JUMPED UP AND RELEASED THE PATIENT FROM THE ARM. THE PATIENT REPORTED A TEMPORARY INCREASE OF PAIN AND A SCARE. PATIENT EXPRESSED CONCERN REGARDING THE MANUFACTURING OF THE DEVICE. THEY THOUGHT A BOLT SHOULD BE PRESENT ALONG WITH THE WELDING. PREVIOUS PROBLEMS WITH THIS UNIT INVOLVED THE PATIENT'S USE OF THE CONTROLLER. THE PT REPORTED THESE CONTROLLER PROBLEMS AS PATIENT ERROR. THE PT VISITED THE PATIENT AFTER THE INCIDENT AND NOTED THAT NO ADDITIONAL INJURY HAD OCCURRED. SEVERAL FOLLOW UP CALLS WERE MADE AND THE PATIENT DID NOT INDICATE ANY CONTINUED PROBLEM DUE TO THE EVENT. HE BROUGHT OUT A SECOND CHAIR TO CONTINUE THERAPY AND NOTED THAT SHE IS PROGRESSING NICELY. THE PT NOTED THAT THIS PRODUCT WAS WELDED BACK TOGETHER BY A FRIEND; IT WILL NOT BE SENT IN FOR REPAIR. THE PT WAS AWARE THAT THE METHOD OF REPAIR VOIDS ALL WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLEX-S CPM PKG BXB ORMED 2035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention