BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9610825-2012-00119

    MDR report key: 2717949 · Received August 15, 2012

    Report

    Report Number
    9610825-2012-00119
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MFR). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, DATING BACK ONE YEAR REVEALED NO OTHER REPORTS OF THIS NATURE AGAINST P/N 8713112C. ONE POWER CORD, PART NUMBER #8713112C, WAS RECEIVED FOR EVAL. THE SAMPLE WAS FORWARDED TO THE MFR, B. BRAUN (B)(4), AND THEIR INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER(B)(4). B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MFR). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, DATING BACK ONE YEAR REVEALED NO OTHER REPORTS OF THIS NATURE AGAINST P/N 8713112C. ONE POWER CORD, PART NUMBER #8713112C, WAS RECEIVED FOR EVAL. THE SAMPLE WAS FORWARDED TO THE MFR, B. BRAUN (B)(4), AND THEIR INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRN

    Patients

    Seq Age Sex Outcome Treatment
    1