BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN/X POWERED COT

    MDR report key: 4950656 · Received July 29, 2015

    Report

    Report Number
    1523574-2015-00073
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    January 5, 2016
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD EVALUATION WAS NOT CONDUCTED ON THIS COT AS AFTER THE INITIAL REVIEW OF PICTURES PROVIDED BY THE CUSTOMER, IT BECAME EVIDENT THE HOOK INSTALLED ON THE FLOOR OF THE AMBULANCE WAS NOT A COMPATIBLE HOOK TO INTERACT WITH THE STRETCHER'S BAIL SYSTEM. FERNO HAD PREVIOUSLY INSTALLED THE PROPER HOOKS FOR THE CUSTOMER'S TRUCKS AFTER PURCHASE OF THE STRETCHER BUT THE TRUCK IN QUESTION WAS NOT ACCESSIBLE AT THE TIME AS IT WAS OFFSITE FOR SERVICE/REPAIR. THE CUSTOMER WAS ADVISED TO LET FERNO KNOW WHEN THE TRUCK WAS AVAILABLE SO THE PROPER HOOK COULD BE INSTALLED. AFTER THE INCIDENT, THE CUSTOMER REPLACED THE HOOK IN THE TRUCTK WITH A HOOK FROM A RESERVE UNIT AND FERNO PROVIDED ANOTHER HOOK TO COMPLETE THE INSTALL INTO THE RESERVE TRUCK. THERE WAS NO MALFUNCTION OF THE DEVICE ITSELF, JUST THE INTERACTION OF THE DEVICE AND THE TRUCK'S FLOOR HOOK. FERNO WAS ADVISED THE CUSTOMER DID RETURN TO THE HOSPITAL ALLEGING FURTHER NECK PAIN. THE CUSTOMER HAS CALLED FERNO TO DISCUSS THE SITUATION. FERNO HAS REQUESTED MEDICAL RECORDS PERTAINING TO THE ALLEGED INJURY; HOWEVER, THE CUSTOMER HAS NOT PROVIDED SUCH RECORDS AND HAS NOT COMMUNICATED WITH FERNO ANY FURTHER. IT IS UNKNOWN IF ANY SERIOUS/PERMANENT INJURY WAS SUSTAINED AS A RESULT OF THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PATIENT UNLOAD THE COT ALLEGEDLY DID NOT CATCH THE SAFETY HOOK AND THE HEAD END OF THE COT LOWERED APPROXIMATELY 12-16 IN. IT IS ALLEGED THE PATIENT LATER REPORTED NECK SORENESS BUT NO INFORMATION REGARDING MEDICAL INTERVENTION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494714 IN/X POWERED COT IN/X POWERED COT FPO FERNO-WASHINGTON, INC. 0015802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other