BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DANTEC KEYPOINT

    MDR report key: 8174326 · Received December 18, 2018

    Report

    Report Number
    3004827015-2018-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 1, 2018
    Report Date
    February 12, 2019
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    GWF
    PMA / PMN Number
    14063930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    QUESTIONAIRE HAS BEEN SENT TWICE TO THE CUSTOMER, HOWEVER THERE HAS BEEN NO UPDATE AS OF YET ON THE ADDITIONAL INFORMATION. A REPLACEMENT HAS BEEN SENT TO THE CUSTOMER AND WE ARE STILL AWAITING TO RECIEVE PRODUCT BACK FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. SHORTEND CAPACITOR (C1003 AND C1016) WERE REPLACED. THE BLOWN (F900)WAS REPLACED. THE SHORTED FET'S (Q901 AN A902) WERE REPLACED. THE UNIT WAS RELABELED, THE UDI LABEL WAS ATTACHED AND THE UNIT WAS CLEANED. INFORMATION RELATING TO THIS COMPLAINT WAS REVIEWED ON THE 31/JAN/2019 BY QUALITY ENGINEER. TEST PAPERWORK FORWARDED TO NATUS BY DANCHELL WAS REVIEWED AND NO RESULTS WERE OBSERVED TO BE OUT OF SPECIFICATION AND NO ISSUES WERE NOTED. SUPPLIER DANCHELL ARE ALERTED TO MAKE THEM AWARE THAT WE HAVE RECEIVED A COMPLAINT (1-580565944) FOR A DANTEC KEYPOINT G4 SYSTEM 9031E0712 LOT/SERIAL NUMBER:2545. WE HAVE ASKED THEM IF THEY HAVE EXPERIENCED THIS ISSUE WITH OTHER SYSTEMS OF THIS TYPE AND IF SO WHAT CHANGES/PRECAUTIONS HAVE THEY CAN MAKE TO PREVENT THIS HAPPENING AND DO THEY KNOW WHAT IS THE ROOT CAUSE FOR THIS ISSUE. DANCHELL RESPONDED TO OUR QUERY WITH AS FOLLOWS: WE HAVE SEEN SHORTED CAPACITOR (C1003 OR C1016) ON 27 PCS SINCE REGISTRATIONS STARTED IN THE END OF 2011. SINGLE STIM AND MULTISTIM ARE USING THE SAME MOTHERBOARD, AND THE 27 PCS. IS COMBINED FOR THE 2 TYPES. THE CAPACITORS WERE M9424P0502 (47UF 35V) AND WAS CHANGED TO M9424P0602 (10UF 50V) IN APRIL 2012. W00617AH ALPINE BIOMED 9031E7325 MOTHERBOARD S USED M9424P0502 (47UF 35V). W00617AJ ALPINE BIOMED 9031E7326 MOTHERBOARD S USED M9424P0602 (10UF 50V). M9424P0602 HAS BEEN USED ONGOING FROM M9424P0602 AND IS STILL USED IN CURRENT VERSION. 22 ERRORS WERE M9424P0502 (47UF 35V) SHORTED. 5 ERRORS WERE M9424P0602 (10UF 50V) SHORTED. I EXPECT THAT THE ROOT CAUSE WAS, THAT THE TANTALUM CAPACITOR WAS 35V FOR THE 22 ERRORS. (LATER CHANGED TO 50V) I DO NOT KNOW THE ROOT CAUSE OF, WHY THE 5 PCS. WITH M9424P0602 (10UF 50V) FAILED SINCE APRIL 2012. THIS ISSUE WILL BE CONTINUED TO BE MONITORED IN THE FUTURE FOR ANY TRENDS RELATING TO THIS ISSUE.

    Description of Event or Problem · 0

    THE EVENT OCCURRED WHILE DOING A NERVE CONDUCTION STUDY TEST. THE PATIENT WAS NOT AFFECTED. THE ONLY EFFECT TO HIM WAS THAT HIS CONSULTATION WAS PROLONGED FOR 15 MINUTES. IT WAS AN OUTPATIENT APPOINTMENT SO THERE WAS NO HOSPITALIZATION REQUIRED. THE DOCTOR HAD TO REPEAT THE EXAMINATION IN OTHER MACHINE.

    Additional Manufacturer Narrative · 1

    WORK ORDER HAS BEEN OBTAINED AND WILL BE REVIEWED. PRODUCT REQUESTED TO BE RETURNED FOR EVALUATION. THE RISK OF THIS COMPLAINT WAS REVIEWED UNDER (B)(4) RISK MANAGEMENT REPORT FOR KEYPOINT FOCUS/G4 SYSTEMS AND THE RESIDUAL RISK FOUND WAS 13. THE RESIDUAL RISK WAS FOUND TO BE ACCEPTABLE BASED OF THE RISK BENEFIT RATIONALE. THE COMPLAINT LOG WAS REVIEWED FOR THE PAST 12 MONTHS FOR THIS PART NUMBER AND PRODUCT LINE. NO SIMILAR COMPLAINTS RECEIVED. NO TREND HAS BEEN OBSERVED. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INJURY INITIALLY REPORTED, DEVICE MALFUNCTION OCCURRED. DATE OF EVENT - REQUESTED BUT INFORMATION NOT PROVIDED. UDI - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. RELEVANT TESTS / LABORATORY DATA - NOT APPLICABLE AS NO PATIENT INJURY REPORTED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: NOT APPLICABLE AS NO PATIENT INJURY REPORTED. LOT # - NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A LOT NUMBER. IMPLANTED DATE (MM/DD/YYYY) - NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. EXPLANTED DATE (MM/DD/YYYY) - NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL # - NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED, CHECK TYPE - NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

    Description of Event or Problem · 1

    DEVICE EMITTED AN ELECTRICAL BURNING SMELL AND SHUT DOWN. NO SMOKE WAS NOTED BUT IT WAS RAISED AS AN INCIDENT AS A POTENTIAL RISK OF FIRE OCCURRING. THE CONSULTANT USING THE EQUIPMENT AT THE TIME RAISED THIS AS AN INCIDENT - NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014815 DANTEC KEYPOINT SINGLE STIM FOR G4 GWF ALPINE BIOMED APS 9031E0712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other