BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILEHELP BASE STATION - IGB-01

    MDR report key: 3533683 · Received December 23, 2013

    Report

    Report Number
    3008101184-2013-00007
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    November 9, 2013
    Report Date
    December 23, 2013
    Manufacturer
    INTEGRITY TRACKING LLC / DBA MOBILEHELP
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE PENDANT LOST ITS TRAINING TO THE BASE STATION IGB-01. THE PENDANT WAS RETRAINED TO THE UNIT BY THE CUSTOMER SUPPORT TECH. THE SYSTEM WAS THEN TESTED AND WORKED AS DESIGNED. THE SUBSCRIBER DID NOT WANT TO REPLACE THE SYSTEM. THE SUBSCRIBER WAS SENT THE SUMMER NEWSLETTER ON 6/20/13, WHICH INCLUDED INSTRUCTIONS ON PRESSING THE BUTTON THE CORRECT WAY TO AVOID LOSS OF TRAINING FROM OCCURRING. THIS ISSUE IS BEING MANAGED IN CAPA (B)(4).

    Description of Event or Problem · 1

    SPOKE WITH (B)(6) WHO REPORTED THAT HIS WIFE, (B)(6) HAD PRESSED HER BLACK WRIST BUTTON (BWB) ON SATURDAY AT 4:45 PM CST (B)(6) 2013 AND THE LED FLASHED BUT THE BASE STATION(BS) DID NOT RESPOND, CLASSIC SYSTEM. MR. (B)(6) WAS WITH HIS WIFE AT THAT TIME WHEN SHE WAS HAVING A SEIZURE IN THE LIVING ROOM SO HE PRESSED THAT BLACK WRIST BUTTON SHE WAS WEARING BUT IT FLASHED AND DID NOT ACTIVATE THE ALARM, THE BASE STATION WAS IN THE SAME ROOM. HE CALLED 911 DIRECTLY AND SHE REQUIRED TRANSPORT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673503 MOBILEHELP BASE STATION - IGB-01 PERSONAL EMERGENCY RESPONSE SYSTEM ILQ INTEGRITY TRACKING LLC / DBA MOBILEHELP IGB-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other