BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OH PACK WITH VKMO 70000

    MDR report key: 4093130 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00385
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    September 26, 2012
    Report Date
    September 27, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. NO PHOTOGRAPHS OF THE KIT WERE PROVIDED FOR INSPECTION. BASED UPON THE COMPLAINT DESCRIPTION, IT WAS DETERMINED THAT THE INNER BLUE WRAP WAS INCORRECTLY FOLDED DURING ASSEMBLY. THE COMPLAINT WAS DISCUSSED WITH THE MANUFACTURING MANAGERS. ALL MCP ASSEMBLERS WERE RETRAINED ON THE PROPER FOLDING OF THE INNER BLUE WRAP. NO FURTHER ACTION IS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INNER BLUE WRAP OF LINE 1 DID NOT HAVE ALL THE CORNER TABS TO ALLOW THE STERILE PERSON TO UNFURL THE INNER WRAP. APPARENTLY, THE OUTER WRAP CONTAINED THE CORNER TABS ("DOG EARS"), BUT THE INNER WRAP DID NOT HAVE ALL THE TABS TO ALLOW PROPER UNWRAPPING AND EXPOSURE OF THE AV LOOP. THE CUSTOMER STATED THIS IS A NEW DEVELOPMENT AND THAT THE PREVIOUS PACKS DID HAVE THIS FEATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506873 OH PACK WITH VKMO 70000 CARDIOPULMONARY DEVICE DSP DATASCOPE CORP BO-TOP 21709 14218-02

    Patients

    Seq Age Sex Outcome Treatment
    1