BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 CHARGER

    MDR report key: 3761439 · Received April 21, 2014

    Report

    Report Number
    0001811755-2014-01405
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, THE DEVICE WAS OVERHEATING AND CAUSING A BURNING SMELL, WAS CONFIRMED. THROUGH FUNCTIONAL EVALUATION, THE SERVICE TECHNICIAN SMELLED EVIDENCE OF OVERHEATING TO THE DEVICE. UPON DISASSEMBLY, THE TECHNICIAN IDENTIFIED BROKEN MODULES, CAUSING COMPONENTS TO REMAIN ON THE PRINTED CIRCUIT BOARD. THE DISPLAYS WERE DIM AND WHEN THE UNIT WAS POWERED UP, MODULE 2 WOULD SHOW ¿CHARGING¿, ¿REPLACE¿, OR ¿NO MODULE¿ WITH NO BATTERY INSERTED. THE INTERIOR OF THE DEVICE WAS FULL OF LINT INCLUDING THE FAN FOR THE POWER SUPPLY. THE PCB ASSEMBLY WAS REPLACED AND 4 MODULES WERE INSTALLED. PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE POWER SUPPLY FAN AND THE REPAIRED CHARGER WAS RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEGUN. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 6 CHARGER WAS OVERHEATING AND CAUSING A BURNING SMELL AT THE USER FACILITY. THE EVENT DID NOT OCCUR DURING A CASE. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 6 CHARGER WAS OVERHEATING AND CAUSING A BURNING SMELL AT THE USER FACILITY. THE EVENT DID NOT OCCUR DURING A CASE. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239674 SYSTEM 6 CHARGER INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1