BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOM STIMULATOR

    MDR report key: 2375846 · Received December 12, 2011

    Report

    Report Number
    3006188092-2011-00001
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 16, 2011
    Report Date
    December 12, 2011
    Manufacturer
    FISCHER MEDICAL TECHNOLOGIES LLC
    Product Code
    JOQ
    PMA / PMN Number
    K991293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EP LAB LOCATED ON HOSP SITE HAD A PT GO INTO VENTRICULAR TACHYCARDIA (VTAC). TOOK PT OFF OF THE BLOOM AND GE MAC LAB EQUIPMENT AND UTILIZED A MANUAL PACEMAKER. THE PROCEDURE WAS AN EP STUDY EVAL FOR A POSSIBLE ABLATION OR DEFIBRILLATOR IMPLANTATION. THE BOOM AND GE MAC LAB EQUIPMENT WAS INITIALLY BEING USED DURING THE CASE UNTIL THE DR BEGAN TRYING DIFFERENT RATES AND THEN THE PT WENT INTO VTAC, THEY USED A HAND HELD PACEMAKER TO MANUALLY STABILIZE THE PT AND THE SINUS RHYTHM WAS RESTORED. PT WAS STATED TO BE OKAY AND A DEFIBRILLATOR WAS NOT NECESSARY/OR USED. S1 INTERVALS WERE INITIALLY SET AT 600 MS, THEN WERE CHANGED TO 590 MS (PAUSE IN STIMULUS) THEN THEY GOT AN UNEXPECTED BURST OF 50 50 MS PULSES. POSSIBLE USE ERROR. THEY NOTED THAT THEY HAVE BEEN USING THIS UNIT CONSTANTLY FOR 2 1/2 YEARS AND THIS WAS THE FIRST TIME THEY HAVE ENCOUNTERED AN ISSUE. THEY HAVE THREE LABS WITH THREE BLOOM UNITS AND USE THEM ON A DAILY BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOM STIMULATOR STIMULATOR FOR ELECTROPHYSIOLOGY JOQ FISCHER MEDICAL TECHNOLOGIES LLC DTU-215B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention