BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA

    MDR report key: 2585247 · Received May 21, 2012

    Report

    Report Number
    2585247
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    April 10, 2012
    Report Date
    May 16, 2012
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE HOLTER RECORDER WAS CONNECTED TO THE PATIENT TO RECORD HEART RATE FOR 48 HOURS. WHEN THE MONITOR WAS TAKEN OFF OF THE PATIENT AND CONNECTED TO THE COMPUTER TO DOWNLOAD THE INFORMATION, NOTHING WAS TRANSFERRED. TEST HAD TO BE REPEATED CAUSING A DELAY IN TREATMENT. THERE ARE SIX ADDITIONAL DEVICES THAT HAD BROKEN CASES WHICH CAUSED THEM TO STOP RECORDING. THESE ALL LOST EITHER PART OR ALL OF THE RECORDED DATA. (EITHER THE BATTERY COMPARTMENT WAS BROKEN SO THE BATTERY WAS NOT SEATED PROPERLY AND THE DEVICE DIDN'T RECORD, OR THE CASE WAS BROKEN SUCH THAT THE BACK OF THE DEVICE WAS NOT SECURE AND THE DEVICE DID NOT OPERATE).======================MANUFACTURER RESPONSE FOR HOLTER RECORDER, ARIA (PER SITE REPORTER).======================MANUFACTURER REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA HOLTER RECORDER MWJ SPACELABS HEALTHCARE ARIA *
    2 ARIA HOLTER RECORDER MWJ SPACELABS HEALTHCARE ARIA *
    3 ARIA HOLTER RECORDER MWJ SPACELABS HEALTHCARE ARIA *
    4 ARIA HOLTER RECORDER MWJ SPACELABS HEALTHCARE ARIA *
    5 ARIA HOLTER RECORDER MWJ SPACELABS HEALTHCARE ARIA *
    6 ARIA HOLTER RECORDER MWJ SPACELABS HEALTHCARE ARIA *
    7 ARIA HOLTER RECORDER MWJ SPACELABS HEALTHCARE ARIA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *