BEUDAMED
    FDA Adverse Event Summary report: N

    MCU

    MDR report key: 5565049 · Received April 8, 2016

    Report

    Report Number
    1119903-2016-00002
    Date Received
    April 8, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 9, 2016
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    IKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT: MCU IS USED FOR CERVICAL NECK ASSESSMENT AND REHABILITATION. THE SYSTEM IS INTENDED TO EVALUATE DEFICITS, INCREASE STRENGTH AND RANGE OF MOTION, AND TO TRACK PATIENT PROGRESS THROUGH THE PROCESS. BTE RECEIVED AN E-MAIL ON MARCH 9, 2016 FROM THE CUSTOMER DESCRIBING AN EVENT IN WHICH THE CABLE RELEASED UNEXPECTEDLY WHILE A PATIENT WAS EXERCISING. THE CABLE RELEASE CAUSED A FLARE UP OF NECK PAIN. NO INJURY WAS REPORTED. BTE TOLD THE CUSTOMER NOT TO USE THE DEVICE UNTIL THE ISSUE IS RESOLVED. THE CUSTOMER ATTEMPTED TO REPAIR THE DEVICE AFTER THE INCIDENT; THIS DID NOT CONTRIBUTE TO THE REPORTED ISSUE. BTE CONTACTED THE CUSTOMER NUMEROUS TIMES TO REQUEST MORE INFORMATION, BUT THE CUSTOMER WAS UNABLE TO BE REACHED UNTIL MARCH 23, 2016. CUSTOMER SERVICE REQUESTED PHOTOGRAPHS OF THE REPORTED ISSUE. ON (B)(6) 2016 THE CUSTOMER SENT PICTURES AND STATED THAT HE WILL BE AWAY AND MAY NOT BE ABLE TO RETURN PHONE CALLS OR E-MAILS UNTIL THE WEEK OF (B)(6) 2016. MCU IS A LARGE EQUIPMENT AND BTE PLANS TO SEND A TECHNICIAN TO THE SITE ONCE THE CUSTOMER RETURNS. THIS IS AN ISOLATED INCIDENT. THE DEVICE IS ON THE MARKET FOR OVER 10 YEARS AND THE CABLE RELATED ISSUE DESCRIBED BY THE CUSTOMER HAS NOT BEEN PREVIOUSLY REPORTED. DEVICE MALFUNCTION IS SUSPECTED BUT CANNOT BE CONFIRMED UNTIL THE TECHNICIAN REVIEWS THE EQUIPMENT. THE INCIDENT INVOLVES ONE UNIT. THE FINAL REPORT SHOULD BE COMPLETED BY JULY 8, 2016. FINAL REPORT 2016-06-24. MCU IS A LARGE STATIONARY EQUIPMENT AND IT IS NOT PRACTICAL TO RETURN THE DEVICE TO BTE. HOWEVER, BTE TECHNICIAN INSPECTED AND REPAIRED THE DEVICE ON THE CUSTOMER SITE. EVALUATION SUMMARY AND THE ROOT CAUSE ARE PROVIDED BELOW. THERE IS NO NEED TO INCLUDE ATTACHMENTS WITH THIS REPORT. AFTER THOROUGH INVESTIGATION, THIS INCIDENT WAS DETERMINED NOT TO BE A REPORTABLE EVENT. NO INJURY WAS REPORTED AND THE DEVICE DID NOT MALFUNCTION AS UNDER NORMAL USE. THE FINAL REPORT IS SENT AS A FOLLOW-UP TO THE INITIAL REPORT. DUE TO DELAYS CAUSED BY THE CUSTOMER, BTE WAS UNABLE TO COMPLETE THE INVESTIGATION IN 30 DAYS. BTE SUBMITTED THE INITIAL REPORT DUE TO THE POSSIBILITY OF DEVICE MALFUNCTION. ON (B)(6) 2016, A BTE TECHNICIAN TRAVELED TO THE CUSTOMER SITE TO ASSESS THE DAMAGE. BTE WAS INFORMED THE CUSTOMER RELOCATED TO A NEW LOCATION. THE TECHNICIAN REMOVED THE DAMAGED CABLE AND INSTALLED THE REPLACEMENT CABLE. THE TECHNICIAN COMPLETED THE INSTALLATION INSPECTION AND VERIFIED THERE WAS NO SLIPPAGE OF THE ALIGNMENT. ON (B)(6) 2016, THE CUSTOMER PROVIDED INFORMATION REGARDING THE EQUIPMENT RELOCATION TIMELINE: IT WAS MOVED (B)(6) 2016 INTO THE NEW BUILDING. THEY RE-OPENED ON (B)(6) 2016. THE SYSTEM WAS TRANSPORTED BY CUSTOMER JUST PRIOR TO THE OCCURRENCE OF THE INCIDENT. INCIDENT REVIEW RESULTS THE DEVICE DID NOT MALFUNCTION AS UNDER NORMAL USE. ROOT CAUSES: USER ERROR: THE MCU WAS TRANSPORTED IN A MANNER THAT DID NOT PREVENT POTENTIAL DAMAGE TO THE SYSTEM. THE SYSTEM WAS TRANSPORTED BY CUSTOMER FROM ONE SITE TO ANOTHER WITHOUT NOTIFICATION TO BTE JUST PRIOR TO THE OCCURRENCE OF THE INCIDENT. CUSTOMER DID NOT CONSULT BTE FOR PROPER TRANSPORT INSTRUCTIONS. MCU WEIGHT STACK MAY HAVE NOT BEEN LOCKED DURING CUSTOMER TRANSPORT LEADING TO THE RESULTING SCENARIO WHERE THE CABLE SLIPPED OUT FROM THE LOCKING MECHANISM. MCU HALO MAY HAVE NOT BEEN LOCKED DURING CUSTOMER TRANSPORT. NO CORRECTIVE ACTION WILL BE ISSUED AT THIS TIME. THE INCIDENT IS NOT ATTRIBUTED TO THE DEVICE MALFUNCTIONING OR INADEQUATE BTE PROCESSES. THIS IS AN ISOLATED INCIDENT.

    Additional Manufacturer Narrative · 1

    MCU IS USED FOR CERVICAL NECK ASSESSMENT AND REHABILITATION. THE SYSTEM IS INTENDED TO EVALUATE DEFICITS, INCREASE STRENGTH AND RANGE OF MOTION, AND TO TRACK PATIENT PROGRESS THROUGH THE PROCESS. BTE RECEIVED AN E-MAIL ON (B)(4) 2016 FROM THE CUSTOMER DESCRIBING AN EVENT IN WHICH THE CABLE RELEASED UNEXPECTEDLY WHILE A PATIENT WAS EXERCISING. THE CABLE RELEASE CAUSED A FLARE UP OF NECK PAIN. NO INJURY WAS REPORTED. BTE TOLD THE CUSTOMER NOT TO USE THE DEVICE UNTIL THE ISSUE IS RESOLVED. BTE CONTACTED THE CUSTOMER NUMEROUS TIMES TO REQUEST MORE INFORMATION, BUT THE CUSTOMER WAS UNABLE TO BE REACHED UNTIL (B)(6) 2016. CUSTOMER SERVICE REQUESTED PHOTOGRAPHS OF THE REPORTED ISSUE. ON (B)(6) 2016 THE CUSTOMER SENT PICTURES AND STATED THAT HE WILL BE AWAY AND MAY NOT BE ABLE TO RETURN PHONE CALLS OR E-MAILS UNTIL THE WEEK OF (B)(6) 2016. MCU IS A LARGE EQUIPMENT AND BTE PLANS TO SEND A TECHNICIAN TO THE SITE ONCE THE CUSTOMER RETURNS. THIS IS AN ISOLATED INCIDENT. THE DEVICE IS ON THE MARKET FOR OVER 10 YEARS AND THE CABLE RELATED ISSUE DESCRIBED BY THE CUSTOMER HAS NOT BEEN PREVIOUSLY REPORTED. DEVICE MALFUNCTION IS SUSPECTED BUT CANNOT BE CONFIRMED UNTIL THE TECHNICIAN REVIEWS THE EQUIPMENT. THE INCIDENT INVOLVES ONE UNIT. THE FINAL REPORT SHOULD BE COMPLETED BY JULY 8, 2016.

    Description of Event or Problem · 1

    CABLE RELEASED UNEXPECTEDLY WHILE A PATIENT WAS EXERCISING ON MCU 2. THE CABLE RELEASE CAUSED A FLARE UP OF NECK PAIN. NO INJURY WAS REPORTED. IF THE REPORTED ISSUE WERE TO RECUR, IT COULD CAUSE NECK SPRAIN.

    Description of Event or Problem · 1

    CABLE RELEASED UNEXPECTEDLY WHILE A PATIENT WAS EXERCISING ON MCU 2. THE CABLE RELEASE CAUSED A FLARE UP OF NECK PAIN. NO INJURY WAS REPORTED. IF THE REPORTED ISSUE WAS CAUSED BY DEVICE MALFUNCTION SUSPECTED BY BTE AND IF IT WERE TO RECUR, IT COULD CAUSE NECK SPRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219769 MCU MCU IKK BTE TECHNOLOGIES, INC. MCU 2

    Patients

    Seq Age Sex Outcome Treatment
    1