BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOM STIMULATOR

    MDR report key: 2392015 · Received December 15, 2011

    Report

    Report Number
    3006188092-2011-00002
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    November 3, 2011
    Report Date
    December 14, 2011
    Manufacturer
    FISCHER MEDICAL TECHNOLOGIES LLC
    Product Code
    JOQ
    PMA / PMN Number
    K991293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EP LAB LOCATED ON HOSPITAL SITE HAD A PATIENT GO INTO VENTRICULAR FIBRILLATION (VF). THE PROCEDURE WAS AN EP STUDY EVALUATION FOR A POSSIBLE ABLATION. PATIENT WAS STATED TO BE OKAY. DEC MODE WAS NOT WORKING PROPERLY. S3 MODE - TIMING WAS SET AT 600MS THEN CHANGED TO 470MS, BUT PACING JUMPED TO 210MS ABRUPTLY AND INDUCED VF. POSSIBLE USE ERROR. THEY NOTED THAT THEY USE THE UNIT ALL THE TIME AND IT IS THEIR ONLY BLOOM UNIT. DID NOT RECEIVE ADDITIONAL INFORMATION WITH INDICATION OF VF UNTIL (B)(6) 2011.

    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