BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET

    MDR report key: 2632564 · Received June 13, 2012

    Report

    Report Number
    2632564
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 13, 2012
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ELDERLY MALE IN ED HAD A NEWLY OPENED DISPOSABLE FINGER PULSE OXIMETER ON. THE PULSE OXIMETER WAS TAPED IN ORDER FOR IT TO REMAIN ON THE FINGER AND OBTAIN AN ACCURATE READING. WHEN THE TAPE WAS REMOVED, THE WIRES WERE EXPOSED RESULTING IN A SHOCK TO THE PATIENT. THERE WAS NO INJURY TO THE PATIENT FROM THE SHOCK. OUR HEALTH SYSTEM HAS JUST RECENTLY STARTED USING THIS BRAND OF DISPOSABLE PULSE OXIMETER. IN ORDER TO OBTAIN AN ACCURATE READING THE STAFF MUST "PLAY WITH IT" AND TAPE IT TO SECURE IT. TO MY KNOWLEDGE, THERE HAVE NOT BEEN ANY OTHER INCIDENTS OF SHOCKING PATIENTS.======================MANUFACTURER RESPONSE FOR MASIMO SET PULSE OXIMETER (PER SITE REPORTER).======================NOTHING SUCH AS THIS HAS PREVIOUSLY OCCURRED TO HIS KNOWLEDGE. HE WILL PICK UP THE DEVICE NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET OXIMETER DQA MASIMO CORPORATION 20064 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR