BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOM

    MDR report key: 2617893 · Received June 1, 2012

    Report

    Report Number
    2617893
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Date of Event
    May 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    FISCHER MEDICAL
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON THE TABLE PREPPED AND DRAPED WITH SHEATHS AND CATHETERS PLACED BY THE DOCTOR. WE WERE UNABLE TO PACE. THE BLOOM WAS NOT COMPLETELY COMMUNICATING WITH OUR WITH OUR GE SYSTEM. THEREFORE WE WERE UNABLE TO COMPLETE THE STUDY. NO HARM TO THE PATIENT.======================MANUFACTURER RESPONSE FOR ELECTROPHSIOLOGY BLOOM, ELECTROPHYSIOLOGY BLOOM (PER SITE REPORTER).======================BIOMED EVALUATED AND REPAIRED THE DEVICE. THE BLOOM STIMULATOR IS NOW FUNCTIONING APPROPRIATELY. CE# 824457-WO # 612701 TROUBLE SHOT PROBLEM, FOUND CONNECTOR FROM BLOOM STIMULATOR WAS PARTIALLY DISCONNECTED. RESEATED CONNECTOR PLUG IN TO BLOOM STIMULATOR, SYS OPS. TESTED GOOD AND RETURNED TO USE AFTER VERBAL RELEASE FROM RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOM GENERATOR, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ FISCHER MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR