BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX CO-OX

    MDR report key: 3901982 · Received February 24, 2014

    Report

    Report Number
    2027541-2014-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 28, 2014
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RT HAS PICTURES ALLEGEDLY SHOWING MARKS ON THE UPPER PORTION OF HIS FOREARM THAT HE CLAIMS ARE ENTRANCE AND EXIT WOUNDS FROM THE ELECTRICAL SHOCK. THE PHOTOS AND THE MARKS HAVE NOT BEEN VERIFIED. THERE IS UNCERTAINTY AS TO WHETHER THE INCIDENT ACTUALLY OCCURRED, OR IF IT WAS STAGED. THE HOSP DIRECTOR STATED THAT THE RT WAS RECENTLY REPRIMANDED FOR BEING RUDE TO A PT AND THE RT WAS CONCERNED THAT HE MIGHT LOSE HIS JOB. THE DIRECTOR DOES NOT BELIEVE THAT THE CLAIMS OF THE RT AND THE LOCATION OF HIS WOUNDS APPEAR TO BE CONSISTENT WITH THE WORKING CONDITIONS OF THE ANALYZER. A FIELD SERVICE ENGINEER (FSE), FROM OUR DISTRIBUTOR, PERFORMED A THOROUGH EVAL OF THE ANALYZER ON-SITE AND FOUND NO SUSPICIOUS MARKS OR EVIDENCE OF A MALFUNCTION. THE FSE STATED THAT THERE WERE NO PROBLEMS WITH THE ANALYZER. A HOSP BIO-MED TECH ALSO EVALUATED THE ANALYZER AND STATED THAT IT WAS OPERATING WELL WITHIN STANDARDS AND WAS SAFE TO USE. SENDX IS CURRENTLY IN THE PROCESS OF HAVING THE ANALYZER SHIPPED BACK FROM THE CUSTOMER FOR FURTHER EVAL AND TESTING. THE INVESTIGATION IS CURRENTLY ON-GOING AND THE CONCLUSION IS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A RESPIRATORY THERAPIST (RT) WAS SHOCKED WHEN HE TOUCHED THE BACK OF THE ABL80 FLEX CO-OX ANALYZER. RT STATED THAT THE ANALYZER, AND A PC NEXT TO IT, WERE TURNED OFF, AND THE BATTERY BACK-UP UNIT THAT THEY WERE PLUGGED INTO WAS ALSO TURNED OFF. RT THEN UNPLUGGED THE ANALYZER FROM THE BATTERY BACK-UP UNIT AND PLUGGED IT DIRECTLY INTO THE GROUND FAULT CIRCUIT INTERRUPTER (GFCI) WALL OUTLET. RT TRIED TO TURN THE ANALYZER ON, BUT IT DIDN'T WORK. HE TURNED THE ANALYZER SLIGHTLY TO THE LEFT SO HE COULD REACH THE POWER RECEPTACLE ON THE BACK OF THE ANALYZER. RT MOVED THE PLUG TO ENSURE THAT IT WAS CONNECTED TO THE ANALYZER AND THAT WAS WHEN HE WAS SHOCKED, AND IT KNOCKED HIM AWAY FROM THE ANALYZER. RT VISITED THE EMERGENCY ROOM. WHILE IT IS UNCERTAIN AS THE WHAT TREATMENT, IF ANY, RT RECEIVED FROM THE ER AFTER EVAL, THERE IS NO STATEMENT OF ANY MEDICAL OR SURGICAL INTERVENTION NEEDED TO PRECLUDE IRREVERSIBLE IMPAIRMENT OR DAMAGE. (REF SENDX COMPLAINT #(B)(4))

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114522 ABL80 FLEX CO-OX ELECTRODE MEASUREMENT, BLOOD-GAS AND CHL SENDX MEDICAL, INC. ABL80

    Patients

    Seq Age Sex Outcome Treatment
    1