BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSIGHT ARC ON LAPTOP

    MDR report key: 5365141 · Received January 13, 2016

    Report

    Report Number
    3004608878-2016-00010
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Report Date
    August 6, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HAW
    PMA / PMN Number
    K946252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION MDR: INITIAL MDR WAS SUBMITTED WITH INCORRECT FACILITY REGULATORY NUMBER# 1222895-2015-00035. THIS MDR IS BEING SUBMITTED UNDER CORRECT FACILITY REGULATORY NUMBER. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/17/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: AFTER THE EVALUATION, IT WAS CONFIRMED VIA PHONE CALL THAT THE ROOT CAUSE WAS A USE ERROR IN WHICH LIQUID HAD BEEN SPILLED ONTO THE LAPTOP AND CAUSED THE MOTHERBOARD TO SHORT OUT. THE DEVICE HISTORY RECORD FOR THE UNIT(S) IS LISTED IN THIS COMPLAINT UNDER LOT CODE/WORK ORDER (B)(4) ON 12-05-2014. A TOTAL OF 1 WAS PRODUCED OF THIS LOT. NO ABNORMALITIES RELATE TO REPORTED INCIDENT FOUND NOR WHERE THERE ANY VARIANCES, MRR'S OR REWORKS ASSOCIATED WITH THIS LOT/WORK ORDER NUMBER. NO SERVICE HISTORY ON FILE. A TWO YEAR LOOK BACK IN TRACKWISE FOR THIS REPORTED FAILURE AND OR RELATED TO "LAPTOP IS BURNT " FOR THIS PRODUCT ID SHOWS THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: IN SUMMARY, QUALITY SENT THE DEFECTIVE PRODUCT TO THE HP SUPPORT CENTER FOR A ROOT CAUSE ANALYSIS. AFTER THE EVALUATION, IT WAS CONFIRMED THAT THE ROOT CAUSE WAS A USE ERROR IN WHICH LIQUID HAD BEEN SPILLED ONTO THE LAPTOP AND CAUSED THE MOTHERBOARD TO SHORT OUT.

    Description of Event or Problem · 1

    CORRECTION MDR: INITIAL MDR WAS SUBMITTED WITH INCORRECT FACILITY REGULATORY NUMBER# 1222895-2015-00035. THIS MDR IS BEING SUBMITTED UNDER CORRECT FACILITY REGULATORY NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22828 NEUROSIGHT ARC ON LAPTOP N/A HAW INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR