BEUDAMED
    FDA Adverse Event Other Summary report: N

    4500 MRI PULSE OXIMETER

    MDR report key: 729158 · Received October 13, 2005

    Report

    Report Number
    1051786-2005-00008
    Event Type
    Other
    Date Received
    October 13, 2005
    Date of Event
    August 25, 2005
    Report Date
    August 26, 2005
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY RETURNED BOTH THE POWER ADAPTER AND THE PULSE OXIMETER FOR EVALUATION. UPON RECEIPT OF BOTH DEVICES, A VISUAL INSPECTION WAS CONDUCTED. BECAUSE THE POWER ADAPTER WAS PULLED INTO THE MRI, OBVIOUS DAMAGE TO THE POWER ADAPTER WAS NOTED. THE POWER ADAPTER WAS TAGGED AS DEFECTIVE AND SENT BACK TO THE CUSTOMER. THE ONLY NOTED DAMAGE TO THE PULSE OXIMETER WAS LOCATED WHERE THE POWER ADAPTER CONNECTS TO THE DEVICE. SOME OF THE POWER CONNECTOR SCREW LOCKS WERE DAMAGED. UPON REPLACEMENT OF THE SCREW LOCKS, THE DEVICE FUNCTIONED PROPERLY. THE PULSE OXIMETER'S POWER ADAPTER CONTAINS A LABEL WHICH INDICATES THE FOLLOWING: "CAUTION! MOUNT TO WALL SOCKET WITH SCREW THRU TAB. KEEP 10 FEET OR MORE AWAY FROM MAGNET. ADAPTER IS MAGNETIC." THE FACILITY CONFIRMED THAT THE ABOVE REFERENCED LABEL CONTAINING THE CAUTION TO KEEP THE POWER ADAPTER 10 FEET OR MORE AWAY FROM THE MAGNET WAS INTACT ON THE POWER ADAPTER. THE LABELING FOR THIS DEVICE PROVIDES CLEAR INSTRUCTIONS TO KEEP THIS POWER ADAPTER AT LEAST 10 FEET OR MORE AWAY FROM THE MAGNET. THE CAUTION STATEMENT REFERENCED-ABOVE IS OUTLINED IN THE OPERATIONS MANUAL AS WELL AS ON THE POWER ADAPTER ITSELF. IN THE EVENT REPORTED, THE POWER ADAPTER WAS MOVED WITHIN 3 FEET OF THE MAGNET. THE TECHNICIAN DID NOT REALIZE THE POWER ADAPTER WAS MAGNETIC AND ASSUMED THAT SINCE THE DEVICE WAS IN THE MRI ROOM THAT IT WAS NOT MAGNETIC. AFTER THE EVENT OCCURRED, THE FACILITY COMMENTED THAT THE LABEL ON THE ADAPTER WAS HARD TO READ SINCE IT IS CLEAR IN COLOR. THE MANUFACTURER WILL PERFORM AN ASSESSMENT AS TO THE CLARITY OF THE LABEL ON THE POWER ADAPTER. UPON COMPLETION OF THIS ASSESSMENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY STATED THAT THEY WERE SETTING UP THE MRI SUITE FOR A PATIENT TO BE SCANNED. THE FACILITY REPORTED THAT THE PULSE OXIMETER'S POWER ADAPTER WAS LESS THAN THREE (3) FEET AWAY FROM THE MAGNET. AS A RESULT, THE PULSE OXIMETER'S POWER ADAPTER WAS PULLED INTO THE MRI AND THE POWER ADAPTER WAS DAMAGED. THE FACILITY STATED THAT THEY HAD A NEWER TECHNICIAN SETTING UP THE PULSE OXIMETER AND THE TECHNICIAN DID NOT REALIZE THAT THE PULSE OXIMETER'S POWER ADAPTER WAS MAGNETIC. THE FACILITY STATED THAT THE TECHNICIAN ASSUMED THAT SINCE THE FACILITY USES THE PULSE OXIMETER IN THE MRI ROOM THAT IT (OR ANY OF THE PULSE OXIMETER'S ACCESSORIES) WAS NOT MAGNETIC. THE FACILITY ALSO INDICATED THAT THEY HAVE A MOBILE MRI UNIT SO THEY OPERATE IN A VERY SMALL SPACE AND EVERYTHING IN THE ROOM IS RELATIVELY CLOSE TO THE MRI'S MAGNETIC FIELD. THE FACILITY STATED THAT THERE WERE NO PATIENTS PRESENT AT THE TIME OF THE INCIDENT AND THERE WERE NO INJURIES TO THE STAFF AS A RESULT OF THE INCIDENT. THE FACILITY WAS ABLE TO PURCHASE A NEW POWER ADAPTER AND THE PULSE OXIMETER IS BACK IN SERVICE AND THERE HAVE BEEN NO ADDITIONAL PROBLEMS WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4500 MRI PULSE OXIMETER PATIENT MONITOR DQA INVIVO CORPORATION 3109-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other