BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER-PRO XT

    MDR report key: 18799131 · Received February 28, 2024

    Report

    Report Number
    0001831750-2024-00319
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    February 5, 2024
    Report Date
    May 10, 2024
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327261639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THAT THE EVENT WAS UNABLE TO BE REPLICATED AND THAT A STRYKER TECHNICIAN WAS NOT NEEDED. THE STRYKER QAE DETERMINED THAT THE ALLEGED ENTIRE UNIT BEING DIFFICULT TO LOAD/UNLOAD INTO THE AMBULANCE WAS NOT DUE TO ANY COMPONENT LEVEL MALFUNCTION BUT WAS LIKELY DUE TO USER ERROR. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY A STRYKER SENIOR QAE MAKING THE CUSTOMER AWARE OF PROPER LOADING/UNLOADING PROCEDURES IN THE POWER PRO XT MANUAL AND BY THE STRYKER QAE ENSURING THAT NOTHING ELSE WAS NEEDED FROM STRYKER.

    Additional Manufacturer Narrative · 0

    IT WAS LATER CONFIRMED THAT THE USER HAD SLIGHT SHOULDER PAIN, DID NOT MISS ANY WORK, AND DID NOT SEEK ANY TREATMENT AS A RESULT OF THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DID NOT CATCH UPON UNLOADING. IN ADDITION, IT WAS REPORTED THAT A USER SUSTAINED AN ON-THE-JOB INJURY (OJI). IT WAS LATER CONFIRMED THAT THE USER HAD SLIGHT SHOULDER PAIN, DID NOT MISS ANY WORK, AND DID NOT SEEK ANY TREATMENT AS A RESULT OF THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DID NOT CATCH UPON UNLOADING. IN ADDITION, IT WAS REPORTED THAT A USER SUSTAINED AN ON-THE-JOB INJURY (OJI). IT WAS LATER CONFIRMED THAT THE USER HAD SLIGHT SHOULDER PAIN, DID NOT MISS ANY WORK, AND DID NOT SEEK ANY TREATMENT AS A RESULT OF THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DID NOT CATCH UPON UNLOADING. IN ADDITION, IT WAS REPORTED THAT A USER SUSTAINED AN ON-THE-JOB INJURY (OJI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445183 POWER-PRO XT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 07613327261639

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other