BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORTAION

    MDR report key: 1480251 · Received September 17, 2009

    Report

    Report Number
    1051786-2009-00009
    Event Type
    Injury
    Date Received
    September 17, 2009
    Date of Event
    August 19, 2009
    Report Date
    August 20, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER REPORTED TO THE DEVICE MANUFACTURER THAT HE ELEVATED THE DEVICE AND COULD NOT FIND ANY PROBLEMS, BUT WAS REQUESTING THE DEVICE MANUFACTURER'S ASSISTANCE IN EVALUATING THE DEVICE FURTHER. THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE TRAVELED TO THE USER FACILITY AND EVALUATED THE DEVICE INVOLVED IN THE REPORTED EVENT. IT WAS FOUND THAT THE ECG CABLE USED DURING REPORTED EVENT WAS PHYSICALLY DAMAGED AT THE RA AND LA LEADS. ADDITIONALLY, THE DEVICE'S WIRELESS SPO2 MODULE WAS CRACKED, THE TOP OF THE DEVICE'S WATER TRAP WAS MISSING AND THE WIRELESS MODULE BATTERIES HAD BROKEN SIDE LOCKING TABS. BOTH THE MISSING TOP OF THE WATER TRAP AND THE DAMAGED ECG LEAD SET WOULD BE OBVIOUS IN EITHER ANY VISUAL INSPECTION OR IN SPECIFIED MAINTENANCE. THE CRACKED WIRELESS SPO2 MODULE AND BATTERIES WITH BROKEN SIDE LOCKING TABS ARE COSMETIC PROBLEMS ONLY AND WOULD NOT HAVE AN IMPACT ON PRODUCT PERFORMANCE. THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE PERFORMED OPERATIONAL AND FUNCTIONAL TESTING ON THE DEVICE ACCORDING TO INTERNAL PROCEDURES. ALL TESTING WAS CONDUCTED WITH A NEW ECG LEAD WIRE SET AND A NEW WATER TRAP. ALL TESTING CONDUCTED BY THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE PASSED AND NO MALFUNCTION OF THE MONITORING SYSTEM WAS DETECTED. THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE CONSULTED WITH THE USER FACILITY'S BIOMEDICAL ENGINEER REGARDING MAINTENANCE INSPECTIONS THAT, PER THE INSTRUCTIONS FOR USE, SHOULD BE DONE ROUTINELY ON THE DEVICE AS WELL AS ON AN ANNUAL AND SEMI-ANNUAL BASIS. ALSO, IN-SERVICE TRAINING COVERING BASIC OPERATION OF THE DEVICE (PER THE INSTRUCTION FOR USE) WAS REQUESTED BY THE USER FACILITY AND THIS TRAINING WAS CONDUCTED DURING THIS SITE VISIT AS WELL. IN DEPTH APPLICATION TRAINING WAS ALSO REQUESTED BY THE USER FACILITY. THIS TRAINING IS CURRENTLY SCHEDULED TO OCCUR IN EARLY OCTOBER. THE DEVICE MANUFACTURER CONCLUDES THAT THE CONDITION OF THE ECG LEAD WIRES WAS THE CAUSE OF THE DEVICE'S REPORTED FAILURE TO FUNCTION AS EXPECTED. USE OF THE USER FACILITY'S DAMAGED ECG LEAD WIRES WHILE ATTEMPTING TO MONITOR A PT PRODUCED AN ECG SIGNAL/WAVEFORM OF NON-CLINICAL QUALITY. THIS QUALITY OF ECG SIGNAL/WAVEFORM WOULD HAVE BEEN RECOGNIZABLE, AND OBVIOUS TO THE USER AS INCORRECT. THE DEVICE MANUFACTURER BELIEVES THAT THE DEVICE PROVIDED AN APPROPRIATE RESPONSE TO THE DETERIORATED CONDITION OF THE ECG LEAD WIRES. THE DEVICE MANUFACTURER DOES NOT CONSIDER THE CONDITION OF THE ECG LEAD WIRES OR THE POOR ECG SIGNAL TO BE A MALFUNCTION OF THE DEVICE SINCE THE INSTRUCTIONS FOR USE PROVIDES PRECAUTIONS AGAINST THE USE OF ACCESSORIES THAT ARE NOT IN PROPER WORKING CONDITION. PER THE INSTRUCTIONS FOR USE: CLEANING: "INSPECT THE ACCESSORY FOR ANY CRACKS, HOLES, TEARS, CUTS, ETC., THAT COULD AFFECT OPERATION, AND REPLACE AS NECESSARY. "BEFORE CONNECTING TO A PT": "STEP 3. ENSURE THAT ALL PT ACCESSORIES BEING UTILIZED (NIBP HOSES, CUFFS, ECG LEAD WIRES, ETC.) ARE LISTED IN THE ACCESSORIES SECTION OF THIS MANUAL. VISUALLY INSPECT ALL ACCESSORIES FOR DAMAGE. REPLACE ANY ACCESSORIES THAT SHOW SIGNS OF DAMAGE OR ABUSE." THE USER FACILITY REPORTED TO THE DEVICE MANUFACTURER THAT THE DEVICE IS BACK IN USE. ADDITIONALLY, DURING THEIR SITE VISIT, THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE OBSERVED SEVERAL MRI CASES WITH THE DEVICE IN USE AND NO ISSUES WERE NOTED. THE DEVICE MANUFACTURER CANNOT RULE OUT THE USE OF THE DEVICE AS A CONTRIBUTING FACTOR IN THE EVENT. WHILE THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE WAS CONDUCTING HIS SITE VISIT, THE USER STATED THAT THEY NOTICED THE PT'S ETCO2 READING DETERIORATING. DESPITE THE DETERIORATION IN THE PT'S ETCO2 READING, THE USER CLAIMED THAT THEY BELIEVED THAT THE DEVICE'S READING WAS ERRONEOUS DUE TO THE ECG PROBLEMS THEY HAD BEEN EXPERIENCING WITH THE DEVICE (AS DESCRIBED ABOVE). AS A RESULT, THE PT WAS NOT CHECKED; THE PT SUBSEQUENTLY CODED, BUT WAS SUCCESSFULLY REVIVED.

    Description of Event or Problem · 1

    THE USER REPORTED EXPERIENCING DIFFICULTY OBTAINING A GOOD ECG WAVEFORM WITH THE DEVICE, SO THE USER SWITCHED TO ANOTHER MONITORING DEVICE. THE USER REPORTED THAT THEY EXPERIENCED THE SAME PROBLEM WITH THE SECONDARY MONITORING DEVICE (SEE REPORT 1051786-2009-00010). WHILE THE USER WAS TROUBLESHOOTING THE MONITORING DEVICES, IT WAS REPORTED THAT THE PT CODED. THE PT WAS SUCCESSFULLY REVIVED. THE USER CLAIMED THAT THE PT WAS CONNECTED TO BOTH THE PRIMARY AND SECONDARY MONITORING DEVICES AT THE SAME TIME WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORTAION 3160 MRI PATIENT MONITOR MWI INVIVO CORPORATION 3160

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention