BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2180481 · Received July 27, 2011

    Report

    Report Number
    6000001-2011-15062
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. THE REPORTED CONDITION OF DAMAGED BATTERY WAS CONFIRMED DUE TO DAMAGED BATTERIES. THE MAIN BATTERIES AND HARNESS WERE REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT USER HAS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. THE REPORTED CONDITION OCCURRED UPON POWER UP. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1