BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 11854248 · Received May 20, 2021

    Report

    Report Number
    3007420694-2021-00071
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 17, 2021
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARJO WAS NOTIFIED ABOUT AN INCIDENT WITH INVOLVEMENT OF THE BATTERY CHARGER FOR SARA 3000 FLOOR LIFT. IT WAS REPORTED THAT MEMBER OF THE CUSTOMER FACILITY STAFF SUSTAINED AN ELECTRIC SHOCK FROM WIRE ON TOP OF BATTERY CHARGER. THE CUSTOMER REPRESENTATIVE STATED THAT THE INVOLVED CAREGIVER HAD A SMALL ELECTRICAL SHOCK (LIKE A TINGLE GOING UP THEIR ARM) AND THAT THIS HAD BROUGHT ON AN EPILEPTIC FIT WITH THE CARER. NO FURTHER DETAILS REGARDING TREATMENT WERE AVAILABLE TO DATE. THE INVOLVED ACCESSORY WAS EVALUATED BY THE ARJO REPRESENTATIVE. ACCORDING TO THE RESULTS OF INSPECTION, THE ARJO REPRESENTATIVE VISUALLY CHECKED WALL-MOUNTED CHARGERS AT THE CUSTOMER'S SITE AND ADVISED TO PERFORM TO PAT TEST, BUT NO FAULTS WERE FOUND. SARA 3000 IS POWERED WITH LOW VOLTAGE SUPPLIED BY THE BATTERY NDA0100-2 TO BE CHARGED WITH BATTERY CHARGER NDA8200, WHICH WAS DELIVERED FOR THE INVOLVED LIFT. PLEASE NOTE THAT THIS PRODUCT¿S INSTRUCTIONS FOR USE INCLUDES INFORMATION RELEVANT FOR ITS SAFE AND CORRECT USE. THE WALL MOUNTED BATTERY CHARGER NDA8200 WAS DESIGNED IN COMPLIANCE WITH IEC 60601-1 SERIES INCLUDING APPLICABLE COLLATERAL STANDARDS AND NATIONAL DEVIATIONS. THE NDA8200 CHARGER IS ALSO COMPLIANT TO EN 60335:1:2012+A11:2014 AD EN 55014-1:2006+A1:2009. BASED ON THE COLLECTED INFORMATION THE EVALUATED BATTERY CHARGERS WERE NOT CONFIRMED TO HAVE HAD ANY MALFUNCTION, WHICH COULD HAVE CONTRIBUTED TO THE ELECTRIC SHOCK. IN SUMMARY, NO MALFUNCTION WITHIN THE BATTERY CHARGER WAS FOUND, SO THE PRODUCT WAS UP TO THE MANUFACTURER¿S SPECIFICATION AFTER THE EVENT. IT IS UNKNOWN IF THE INVOLVED BATTERY CHARGER WAS USED FOR ITS PURPOSE, WHEN THE INCIDENT TOOK PLACE, BUT THE ALLEGED ELECTRIC SHOCK OCCURRED UPON CONTACT OF STAFF MEMBER WITH THE CHARGER. THE COMPLAINT WAS ASSESSED AS REPORTABLE DUE TO INDICATION THAT THE CAREGIVER ALLEGEDLY HAD AN ELECTRIC SHOCK FROM THE CHARGER CABLE.

    Additional Manufacturer Narrative · 1

    THE INVOLVED ACCESSORY WAS EVALUATED BY THE ARJO REPRESENTATIVE. ACCORDING TO THE RESULTS OF INSPECTION, THE ARJO REPRESENTATIVE VISUALLY CHECKED WALL-MOUNTED CHARGERS AT THE CUSTOMER'S SITE AND ADVISED TO PERFORM TO PAT TEST, BUT NO FAULTS WERE FOUND. THE INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED IN THE NEXT REPORT.

    Description of Event or Problem · 1

    ARJO WAS NOTIFIED ABOUT AN INCIDENT WITH INVOLVEMENT OF THE BATTERY CHARGER FOR SARA 3000 FLOOR LIFT. IT WAS REPORTED THAT MEMBER OF THE CUSTOMER FACILITY STAFF SUSTAINED AN ELECTRIC SHOCK FROM WIRE ON TOP OF BATTERY CHARGER. THE CUSTOMER REPRESENTATIVE STATED THAT THE INVOLVED CAREGIVER HAD A SMALL ELECTRICAL SHOCK (LIKE A TINGLE GOING UP THEIR ARM) AND THAT THIS HAD BROUGHT ON AN EPILEPTIC FIT WITH THE CARER. NO FURTHER DETAILS REGARDING TREATMENT WERE AVAILABLE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752653 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH POLSKA SP. Z O.O. HEA0002-UK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other