BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE EMERGENCY CART

    MDR report key: 7006424 · Received November 7, 2017

    Report

    Report Number
    7006424
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    June 6, 2017
    Report Date
    September 14, 2017
    Manufacturer
    INTERMETRO INDUSTRIES CORP.
    Product Code
    BZN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDICATION TRAY ON TOP OF CRASH CART IS NOT SECURED BY LOCK. ABOUT 4 MONTHS AGO, IT WAS REPORTED THAT THE TOP DRAWER CONTAINING THE MEDICATION TRAY WAS NOT SECURE WITH THE PLASTIC LOCK IN PLACE ON THE NEW CRASH CART. PATIENT SAFETY ASSESSED THE CRASH CART AND NOTED: THE TOP CAVITY SECURITY SEAL INTACT. THE ABILITY TO PUSH THE TOP COVER BACK AND PULL IT UP WITHOUT BREAKING THE SECURITY SEAL . DISTRIBUTION WAS NOTIFIED AND WAS ASKED IF IT COULD BE IDENTIFIED WHERE THIS MODEL CART WAS LOCATED WITHIN THE HOSPITAL. DISTRIBUTION WOULD IMMEDIATELY CHANGE OUT THE CRASH CART WITH THE OLDER MODEL CRASH CART. PATIENT SAFETY AND PHARMACY COLLABORATED AND WENT TO DISTRIBUTION TO COME UP WITH A PLAN. THE MANUFACTURER AND DISTRIBUTOR WERE CONTACTED. THE MANUFACTURER PROVIDED THE CLINICAL PRODUCT UPDATES DOCUMENT ADDRESSING THE ISSUE. THE DISTRIBUTOR AGREED TO SEND A NUMBER OF METRO SECURITY SEALS (LEC320) AT NO CHARGE TO TRIAL. LASTLY A SIMILAR SECURITY SEAL MADE BY HEALTHCARE LOGISTICS, HAD BEEN ORDERED. REPLACE AS MANY OF THE NEWER CRASH CARTS WITH THE OLDER MODEL UNTIL THE NEWER MODEL TOP CAVITY TRAY CAN BE SECURED. MANUFACTURER RESPONSE FOR CRASH CART, METRO LIFELINE ANTIMICROBIAL (PER SITE REPORTER): ATTEMPT WAS MADE TO TALK TO MANUFACTURER AND INSTEAD COMMUNICATION WAS WITH DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787633 LIFELINE EMERGENCY CART CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN INTERMETRO INDUSTRIES CORP. C05-990A

    Patients

    Seq Age Sex Outcome Treatment
    1