BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS INTEGRIS H

    MDR report key: 4387175 · Received December 30, 2014

    Report

    Report Number
    MW5039954
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    October 13, 2014
    Report Date
    December 29, 2014
    Manufacturer
    PHILIPS
    Product Code
    IZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FILMS FROM BIVENTRICULAR PERMANENT PACEMAKER PLACEMENT AND ABLATION UNABLE TO BE SENT TO PERMANENT STORAGE. PHILIPS SERVICE REP EVALUATED EQUIPMENT AND FELT REASON FILMS WOULD NOT BE SENT WAS DUE TO THE CASE FILE BEING CORRUPT. FILMS HAD TO BE DELETED FROM EQUIPMENT. CATH LAB 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858312 PHILIPS INTEGRIS H XRAY SYSTEM IZF PHILIPS ERROR

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR