BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 1941177 · Received December 8, 2010

    Report

    Report Number
    1831750-2010-04632
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE CUSTOMER INFORMED THE SERVICE TECH THAT THEY REQUIRED PARTS TO DO THEIR OWN REPAIR ON ONE OF THEIR BEDS. RESULTS: FOOT END POTENTIOMETER, COIL CORD. CONCLUSION: THE CUSTOMER DOES THEIR OWN REPAIRS. WE HAVE NOT YET BEEN ABLE TO OBTAIN FURTHER INFORMATION, BUT IT IS KNOWN THAT THESE PARTS CAN FAIL WHEN THE BED IS IN A POSITION THAT IS NOT OPTIMAL FOR MEDICAL INTERVENTION/CPR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ORDERED A POTENTIOMETER, COIL CORD, AND CPU BOARD TO REPAIR ONE OF THEIR BEDS. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED A/C POWERED HOSPITAL BED FNL STRYKER CORP., MEDICAL DIVISION 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1