BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED RAD, REFURBISHED TRANSESOPHAGEAL

    MDR report key: 1714324 · Received June 4, 2010

    Report

    Report Number
    MW5016257
    Event Type
    Injury
    Date Received
    June 4, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 4, 2010
    Manufacturer
    MED RAD, MULTI VENDOR SERVICES
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MED RAD PROVIDES REPAIR AND SALE OF REFURBISHED TRANSESOPHAGEAL -TEE- PROBES. THE REPAIR SERVICE OF MED RAD IS KNOWN AS MULTI VENDOR SERVICE OR MVS. WE HAD SENT THEM OUR TEE PROBE IN (B) (6) 2010 FOR SERVICE. THEY THEN SENT US A REFURBISHED PROBE AS A LOANER WHILE OURS WAS GETTING REPAIRED. THIS REFURBISHED PROBE AND AT LEAST 8 OTHER PROBES AFTER THIS ONE HAVE FAILED AN ELECTRICAL LEAKAGE TEST AT ARRIVAL TO OUR FACILITY OR AFTER PERFORMING A HANDFUL OF PROCEDURES. FAILING AN ELECTRICAL LEAKAGE TEST INDICATES THAT FLUIDS ARE PENETRATING THE PROTECTIVE COATING ON THE PROBE. THIS POSES AN SHOCK HAZARD TO THE PT AS WELL AS TRANSFER OF DISEASES IN THE FLUID. MED RAD REFUSES TO BELIEVE THAT THEY HAVE A QUALITY ASSURANCE ISSUE AND CONTINUES TO SEND US PROBES THAT HAVE LEAKAGE PROBLEMS. DURING THIS PROCESS WE HAVE HAD OUR ELECTRICAL LEAKAGE TESTING DEVICE CALIBRATED TO ENSURE IT IS NOT AN ISSUE WITH OUR TESTING UNTIL MED RAD ALSO SENT US THEIR TESTING DEVICE AND THEIR PROBES HAVE FAILED USING THAT DEVICE AS WELL. MOST FACILITIES DO NOT USE ELECTRICAL LEAKAGE TESTING DEVICES AND MAY NOT BE AWARE OF THIS ISSUE WITH MED RADS TEE PROBES. THEY HAVE ALSO WENT FROM SAYING THE PROBES THAT WE SENT THEM FOR SIMPLE REPAIR ARE NOW UNREPAIRABLE. DATES OF USE: (B) (6) 2010 - (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED RAD, REFURBISHED TRANSESOPHAGEAL TEE PROBE IYO MED RAD, MULTI VENDOR SERVICES

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O