BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2185182 · Received July 22, 2011

    Report

    Report Number
    1061932-2011-00672
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 6, 2009
    Report Date
    July 11, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THE POWERVAR LINE CONDITIONER WAS BYPASSED BY THE HOSPITAL'S ELECTRICIAN AND REMAINED UNUSED. THE UPS (UNINTERRUPTIBLE POWER SUPPLY) WAS SUBSEQUENTLY REPLACED IN (B)(4) (DATE NOT AVAILABLE) FOR THE CUSTOMER BY A FIELD SVC ENGINEER. THOUGH REQUESTED, THE LINE CONDITIONER AND UPS IN USE AT THE TIME OF THE INCIDENT WERE NOT RETURNED FOR INVESTIGATION IN ROOT CAUSE. ALTHOUGH OFFERED THROUGH BECKMAN COULTER INC (BCI) THE UPS AND LINE CONDITIONER ARE NOT BCI PRODUCTS. PER BCI COMPLIANCE ENGINEER THE AREA ON THE LH750 AROUND THE UPLOAD BAY HAS NO HIGH VOLTAGE POINTS AROUND IT. THE FACT THAT THE OPERATOR RECEIVED A "SHOCK" MAY BE DUE TO STATIC ELECTRICITY. IF, HOWEVER, THE UPS OR LINE CONDITIONER WERE FAULTY, THIS MAY HAVE CAUSED A POTENTIAL SHOCK CONDITION. BUT IF THIS WERE THE CASE, THEN ALL SURFACES WOULD HAVE BEEN ELECTRICALLY CHARGED, NOT JUST THE TRAY AREA. THERE IS INSUFFICIENT INFO PROVIDED TO DETERMINE WHAT EXACTLY MAY HAVE HAPPENED. IN ORDER TO COMPLETELY ELIMINATE THE POSSIBILITY OF A SHOCK HAZARD BEING PRESENT, THE ENTIRE SYSTEM, INCLUDING THE UPS, LINE CONDITIONER AND THE LH750 SYSTEM SHOULD HAVE BEEN TESTED FOR GROUNDING INTEGRITY ON-SITE, THOUGH THIS WAS NOT RECORDED BY SITE ELECTRICIAN. WITHOUT THAT, IT IS NOT COMPLETELY POSSIBLE TO RULE OUT THAT A SHOCK HAZARD WAS PRESENT. THE ROOT CAUSE REMAINS UNK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING SHOCKED TWICE WHEN TRYING TO REMOVE CASSETTES FROM THE UNLOAD BAY OF THE LH750 HEMATOLOGY ANALYZER. THE CUSTOMER WORKED WITH THE HOSPITAL'S MAINTENANCE STAFF AND WAS TOLD TO DISCONNECT THE POWERVAR 4.0 LINE CONDITIONER FROM THE INSTRUMENT SYSTEM AS THE LINE CONDITIONER WAS "VERY HOT." PER THE CUSTOMER, THE HOSPITAL'S ELECTRICIAN CHECKED THE INSTRUMENT AND EVERYTHING WAS "ALRIGHT." NO OTHER LAB PERSONNEL HAD EXPERIENCED A SHOCK WHEN WORKING WITH THE INSTRUMENT. THE TECHNOLOGIST WHO DID FEEL A SHOCK LATER STATED IT MIGHT HAVE BEEN A STATIC CHARGE. SHE WAS NOT WEARING ESD (ELECTROSTATIC DISCHARGE) PROTECTIVE GLOVES AT THIS TIME OF THE INCIDENT. THERE WERE NO REPORTS OF ANYONE SEEKING MEDICAL ATTENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK