BEUDAMED
    FDA Adverse Event Other Summary report: N

    NK PEDIATRIC STRETCHER

    MDR report key: 251257 · Received November 23, 1999

    Report

    Report Number
    MW1017629
    Event Type
    Other
    Date Received
    November 23, 1999
    Date of Event
    January 1, 1999
    Report Date
    November 22, 1999
    Manufacturer
    N.K. MEDICAL PRODUCTS, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT HAS MALFUNCTIONED. RPTR WANTS TO ADVISE THE FDA OF A REPORTABLE ADVERSE EVENT. RPTR'S CO SELLS MOSTLY NEW AND SOME RECONDITIONED MEDICAL EQUIPMENT. THE CO IS LICENSED IN HIS STATE. RECENTLY RPTR'S CO SOLD A NEW PEDIATRIC STRETCHER TO A HOSP. IMMEDIATELY AFTER THE PRODUCT WAS PUT INTO USE BY THE FACILITY, IT MALFUNCTIONED CAUSING INJURY TO TWO DIFFERENT NURSES WHO USED THE PRODUCT. RPTR WAS TOLD BY THE HEAD NURSE OF THE AMBULATORY SURGERY CENTER AT THE FACILITY THAT AN INCIDENT REPORT WAS WRITTEN UP BECAUSE OF THE INJURY. THIS COULD BE CLASSIFIED AS A REPORTABLE ADVERSE EVENT ALTHOUGH RPTR IS NOT CERTAIN IF THE FACILITY REPORTED THE EVENT TO THE FDA. THE DEFECTIVE PEDIATRIC STRETCHER WAS RETURNED TO RPTR, HOWEVER, BECAUSE IT WAS DEEMED BY THE FACILITY TO BE UNSAFE FOR USE. AFTER VIDEOTAPING JUST HOW BADLY THIS PRODUCT IS MALFUNCTIONING, RPTR RETURNED THE PRODUCT TO THE MFR. MFR EXPRESSED NO INTEREST IN CORRECTING THE SERIOUS DESIGN FLAWS OF THIS PRODUCT, AND UNFORTUNATELY, RPTR HAS YET TO RECEIVE FULL CREDIT FOR THIS DEFECTIVE PRODUCT THAT WAS RETURNED TO THE MFR. RPTR WILL NOT BE PURCHASING ANY MORE MEDICAL EQUIPMENT FROM MFR. RPTR MADE AN 8 MINUTE VIDEOTAPE SHOWING THIS DEFECTIVE PEDIATRIC STRETCHER WHICH IS SELF EXPLANATORY. THE MFR HAS SIMILAR SAFETY PROBLEMS WITH THE DESIGN OF ITS PEDIATRIC CRIB. NO SERIAL NUMBER LOCATED ANY PLACE ON THIS NEW PEDIATRIC STRETCHER. RPTR HAS BEEN IN THIS BUSINESS FOR OVER 20 YEARS AND NEVER BEFORE HAS SEEN SUCH A POORLY DESIGNED PRODUCT THAT POSES SUCH A SIGNIFICANT THREAT TO BOTH THE PTS AND THE NURSES USING THE PRODUCT. A CHILD COULD EASILY HAVE HIS OR HER HAND BROKEN OR SEVERED BY THIS PEDIATRIC STRETCHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NK PEDIATRIC STRETCHER PEDIATRIC STRETCHER FPO N.K. MEDICAL PRODUCTS, INC. 2010-EL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other