BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DINAMAP PRO 100

    MDR report key: 4240901 · Received November 10, 2014

    Report

    Report Number
    3008729547-2014-00012
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 28, 2014
    Manufacturer
    CRITIKON DE MEXICO
    Product Code
    DXN
    PMA / PMN Number
    K002248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED REPORT VIA USER FACILITY REPORT (B)(4).PATIENT DATA NOT CURRENTLY AVAILABLE.MANUFACTURE DATE NOT KNOWN.

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THE BATTERY WAS A SECOND SOURCE BATTERY. THE BATTERY NAME IS (B)(6) INC. ITEM #(B)(4) OUTPUT 12V 2.3AH. THIS IS NOT AN APPROVED GE BATTERY. THE APPROVED BATTERY IS GE#(B)(4) AND IS DESIGNED FOR USE IN PROSERIES MONITORS. USERS ARE INSTRUCTED IN THE OPERATOR'S MANUAL TO ONLY USE THIS BATTERY. PROSERIES OPERATOR'S MANUAL (B)(6) PAGE 14: WHEN IT IS NECESSARY TO REPLACE THE BATTERY, REFER TO THE "COMPATIBILITY TABLE AND REORDER CODES" LISTED IN APPENDIX D. TO ENSURE FULL CHARGE CYCLES, REPLACE ONLY WITH A RECOMMENDED BATTERY. PAGE 95: BATTERY, 12V LEAD ACID (B)(4). PAGE 102: REPLACEMENT BATTERIES MAY BE OBTAINED FROM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES. NOTE: THE REPLACEMENT PART NUMBER OF THE BATTERY IS (B)(4). DO NOT USE OTHER TYPES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DINAMAP WOULD NOT CHARGE THE INTERNAL BATTERY WHEN PLUGGED INTO THE AC RECEPTACLE. THE CUSTOMER REPORTS THE BATTERY OVERHEATED AND EXPANDED TO THE POINT IT HAD TO BE REMOVED DUE TO EXTREME EXPANSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721907 DINAMAP PRO 100 NON-INVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM DXN CRITIKON DE MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1