BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFLOW IV FLUID/BLOOD WARMER, NO CE MARK

    MDR report key: 4962022 · Received August 3, 2015

    Report

    Report Number
    3010838917-2015-00009
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    Manufacturer
    VITAL SIGNS
    Product Code
    LGZ
    PMA / PMN Number
    K130867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONS/CHANGES: PATIENT IDENTIFIER - (B)(6). MANUFACTURER NAME, CITY AND STATE - CHANGED TO (B)(4). MDR REPORTING CONTACT NAME AND ADDRESS - ADDED THE SITE DETAILS FOR (B)(4) FACILITY. DATE RECEIVED BY MANUFACTURER - 08/30/2016 (DATE EMAIL RECEIVED FROM FDA WITH INSTRUCTIONS TO CORRECT THE SITE REGISTRATION NUMBER). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND AN EVALUATION INCLUDING FUNCTIONAL TESTING WERE PERFORMED. THE INVESTIGATION RESULTS CONCLUDED THAT THIS UNIT WAS BURNT. IMPROPER OR EXCESSIVE HIGH VOLTAGE WAS APPLIED TO THE WARMER, WHICH CAUSED THE INPUT FILTER CAPACITATORS AND AREA AROUND THEM TO BURN UP. THIS WAS MOST PROBABLY CAUSED BY THE CUSTOMER CONNECTING THE UNIT TO AN INCORRECT POWER SOURCE. THE CUSTOMER WAS SENT THE OPERATING MANUAL FOR THIS PRODUCT WITH THE RECOMMENDATION TO FOLLOW THE INDICATED APPROVED POWER SOURCES FOR THIS PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND SHOWED THERE WERE NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS THAT WOULD HAVE CONTRIBUTED TO THIS ISSUE. A 12-MONTH REVIEW OF COMPLAINT DATA WAS PERFORMED AND DID NOT IDENTIFY ANY OTHER RELATED ISSUES.

    Description of Event or Problem · 1

    CUSTOMER STATED TO CAREFUSION CUSTOMER SERVICE VIA TELEPHONE "PRODUCT WON'T HEAT UP, SAYS "NOT HEATING" IT WAS CONFIRMED THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505703 ENFLOW IV FLUID/BLOOD WARMER, NO CE MARK WARMER, THERMAL, INFUSION FLUID LGZ VITAL SIGNS 980105VSD 40110573

    Patients

    Seq Age Sex Outcome Treatment
    1