BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INX FOR INLINE WITH DWL

    MDR report key: 9578116 · Received January 10, 2020

    Report

    Report Number
    1523574-2020-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 7, 2020
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790001339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO FERNO FOR EVALUATION. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED. THE ROOT CAUSE WAS ATTRIBUTED TO THE IMPROPER MOUNTING OF THE IV POLE TO THE COT. THE IV POLE WAS MOUNTED OVER A STORAGE NET WHICH ALLOWED THE POLE TO GET CAUGHT IN THE LEG OF THE COT DAMAGING THE COMPOSITE ARMS AND THE SENSORS. THE COT WAS REPAIRED AND APPROVED FOR SERVICE. NO FURTHER DETAILS WERE PROVIDED REGARDING THE PATIENT'S ALLEGED INJURY.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED WHILE LOWERING THE COT INTO POSITION TO LOAD A PATIENT, THE COT ALLEGEDLY MADE A CRUNCHING SOUND AND THE COT WOULD NOT FUNCTION. THE MEDICS WERE ABLE TO LOAD THE COT BACK INTO THE AMBULANCE; HOWEVER THEY MADE THE DECISION TO WALK THE PATIENT TO THE AMBULANCE FOR FINAL TRANSPORT. AT THE HOSPITAL, A BACKUP UNIT WAS USED TO COMPLETE THE TRANSFER INTO THE HOSPITAL. THERE WERE NO ADVERSE EFFECTS OR DELAY AS A RESULT.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED WHILE LOWERING THE COT INTO POSITION TO LOAD A PATIENT, THE COT ALLEGEDLY MADE A CRUNCHING SOUND AND THE COT WOULD NOT FUNCTION. THE MEDICS WERE ABLE TO LOAD THE COT BACK INTO THE AMBULANCE; HOWEVER THEY MADE THE DECISION TO WALK THE PATIENT TO THE AMBULANCE FOR FINAL TRANSPORT. AT THE HOSPITAL, A BACKUP UNIT WAS USED TO COMPLETE THE TRANSFER INTO THE HOSPITAL. THERE WERE NO ADVERSE EFFECTS OR DELAY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41788 INX FOR INLINE WITH DWL INX FOR INLINE WITH DWL FPO FERNO-WASHINGTON, INC. 0015811 00190790001339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other