BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2000

    MDR report key: 1641177 · Received January 20, 2010

    Report

    Report Number
    9611343-2010-00002
    Event Type
    Injury
    Date Received
    January 20, 2010
    Date of Event
    October 30, 2009
    Report Date
    January 20, 2010
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K022322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE WAS UNABLE TO PERFORM A LOG REVIEW OF THE REPORTED EVENT AS THE LOGS WERE NOT PROVIDED AT THE TIME OF THIS REPORT. THERE IS NO EVIDENCE OF EQUIPMENT MALFUNCTION BASED UPON THE INFO THE CUSTOMER PROVIDED. THE ROOT CAUSE OF THE REPORTED SKIN INJURY WAS DETERMINED TO BE DUE TO EXTENDED FLUOROSCOPY TIME. THE ATTACHED PAGES OF THE INNOVA 2000 OPERATOR MANUAL CONTAIN REFERENCES TO APPROPRIATE DOSAGE LEVELS AND MEASURES TO REDUCE DOSAGE. A COMPLAINT REVIEW FROM JAN 2007 TO PRESENT WAS COMPLETED FOR ANY DETERMINISTIC EFFECTS OF RADIATION. SIXTEEN EVENTS WERE REPORTED TO GE. THERE WAS NO EVIDENCE OF EQUIPMENT MALFUNCTION IN ANY OF THE CASES REPORTED. ADD'L INFO FROM THE VOLUNTARY REPORT: CARDIOVASCULAR IMAGING SYSTEMS. MODEL#: 2224559. (B) (4): OTHER HEALTHCARE PROFESSIONAL.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A FLUOROSCOPIC SKIN INJURY FOLLOWING A HEART CATHETERIZATION AND PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY). THE ESTIMATED SKIN DOSE WAS 16.4 GRAY (GY) DURING THE EXAMINATION WITH 94 MINUTES OF FLUOROSCOPY. THE PT EXHIBITED SKIN REDDENING WITHIN 24 HOURS AND AT 39 DAYS POST PROCEDURE, HAD PROGRESSED TO SEVERE REDDENING WITH AREAS OF PEELING AND BLISTERS. THE DOSE ESTIMATE WAS DERIVED FROM THE MACHINE SERVICE LOGS. ACTUAL TABLE HEIGHT VERSUS THE INTERVENTIONAL REFERENCE POINT, CONVERSION OF DOSE-TO-AIR TO DOSE-TO-TISSUE, PERCENT OF TIME IN A SINGLE LOCATION AND BACK-SCATTER FACTOR WERE MODIFYING FACTORS. THERE IS NO ALLEGATION OF EQUIPMENT MALFUNCTION. ADD'L INFO FROM THE VOLUNTARY REPORT: FLUOROSCOPIC SKIN INJURY FOLLOWING A HEART CATHETERIZATION AND PTCA (POBA). THE ESTIMATED SKIN DOSE WAS 16.400 MGY, WHICH EXCEEDS THE JOINT COMMISSION SENTINEL EVENT REPORTING CRITERIA. (B) (4) NOTIFICATION WAS SUBMITTED ON 5 NOV 2009. THE PT EXHIBITED SKIN REDDENING WITHIN 24 HOURS AND AT 39 DAYS POST PROCEDURE HAD PROGRESSED TO SEVERE REDDENING WITH AREAS OF PEELING AND BLISTERS. THE DOSE ESTIMATE WAS DERIVED FROM THE MACHINE SERVICE LOGS. ACTUAL TABLE HEIGHT VERSUS THE INTERVENTIONAL REFERENCE POINT, CONVERSION OF DOSE-TO-AIR TO DOSE-TO-TISSUE, PERCENT OF TIME IN A SINGLE LOCATION AND BACK-SCATTER FACTOR WERE MODIFYING FACTORS. DOSE: 16,400 MILLIGRAY. FREQUENCY: 94 MINUTES. ROUTE: FLUOROSCOPY. DATES OF USE: (B) (6) 2009. DIAGNOSIS: HEART CATH AND PTCA. THE PT HAD BEEN ON CHRONIC ASPIRIN AND PLAVIX THERAPY PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 VASCUALR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS 224559 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other