BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON CARDIOLOGY HEMO

    MDR report key: 1593049 · Received January 28, 2010

    Report

    Report Number
    9616760-2010-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 27, 2010
    Manufacturer
    MCKESSON ISRAEL LTD
    Product Code
    DQK
    PMA / PMN Number
    K050561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON PERFORMED AN INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE EVENT. IT WAS FOUND THAT IF SOUND PROMPTS ARE CONFIGURED ON THE HORIZON CARDIOLOGY HEMO SYSTEM, A CONFLICT BETWEEN THE INTEGRATED SOUND COMPONENT ON THE REAL-TIME MONITORING COMPUTER AND THE PROCESS OF ACQUIRING PT'S PHYSIOLOGICAL PARAMETERS RESULTED IN LOSS OF PARTS OF THE ECG WAVEFORMS WHEN THERE WAS ACTIVITY USING THE SOUND COMPONENT. THE INTEGRATED SOUND COMPONENT WAS DISABLED ON (B)(6) 2010 AND WAS PERMANENTLY REPLACED WITH AN ADDITIONAL SOUND ADAPTER ON (B)(6) 2010. THE RESOLUTION OF THE ISSUE WAS VALIDATED WITH THE CLINICAL STAFF ON-SITE. NO OTHER EVENTS WERE REPORTED SINCE DISABLING THE INTEGRATED SOUND COMPONENT ON (B)(6) 2010.

    Description of Event or Problem · 1

    ON (B)(6) 2009, MCKESSON RECEIVED A REPORT FROM A CLINICAL SITE, WHERE THE HORIZON CARDIOLOGY HEMO SYSTEM IN THE CATHETERIZATION LAB PRESENTED UNUSUAL ECG WAVEFORMS ON THE REAL TIME MONITOR. THE HOSP REPORTED THAT BASED ON THE PHYSICIAN'S INTERPRETATION OF THE ECG WAVEFORMS, AFTER THE PROCEDURES WERE COMPLETE, TWO PTS WERE TRANSFERRED TO ANOTHER AREA OF THE HOSP FOR ADDITIONAL OBSERVATION. DURING THE ADDITIONAL OBSERVATION, NO UNUSUAL ECG RHYTHMS WERE DETECTED USING OTHER PHYSIOLOGICAL MONITORING EQUIPMENT. THE HOSP ALSO REPORTED THAT NO FURTHER TREATMENT WAS PROVIDED.

    Additional Manufacturer Narrative · 2

    MCKESSON PERFORMED AN INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE EVENT. IT WAS FOUND THAT IF SOUND PROMPTS ARE CONFIGURED ON THE HORIZON CARDIOLOGY HEMO SYSTEM, A CONFLICT BETWEEN THE INTEGRATED SOUND COMPONENT ON THE REAL-TIME MONITORING COMPUTER AND THE PROCESS OF ACQUIRING PT'S PHYSIOLOGICAL PARAMETERS RESULTED IN LOSS OF PARTS OF THE ECG WAVEFORMS WHEN THERE WAS ACTIVITY USING THE SOUND COMPONENT. THE INTEGRATED SOUND COMPONENT WAS DISABLED ON (B)(6) 2010 AND WAS PERMANENTLY REPLACED WITH AN ADDITIONAL SOUND ADAPTER ON (B)(6) 2010. THE RESOLUTION OF THE ISSUE WAS VALIDATED WITH THE CLINICAL STAFF ON-SITE. NO OTHER EVENTS WERE REPORTED SINCE DISABLING THE INTEGRATED SOUND COMPONENT ON (B)(6) 2010.

    Description of Event or Problem · 2

    ON (B)(6) 2009, MCKESSON RECEIVED A REPORT FROM A CLINICAL SITE, WHERE THE HORIZON CARDIOLOGY HEMO SYSTEM IN THE CATHETERIZATION LAB PRESENTED UNUSUAL ECG WAVEFORMS ON THE REAL TIME MONITOR. THE HOSP REPORTED THAT BASED ON THE PHYSICIAN'S INTERPRETATION OF THE ECG WAVEFORMS, AFTER THE PROCEDURES WERE COMPLETE, TWO PTS WERE TRANSFERRED TO ANOTHER AREA OF THE HOSP FOR ADDITIONAL OBSERVATION. DURING THE ADDITIONAL OBSERVATION, NO UNUSUAL ECG RHYTHMS WERE DETECTED USING OTHER PHYSIOLOGICAL MONITORING EQUIPMENT. THE HOSP ALSO REPORTED THAT NO FURTHER TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON CARDIOLOGY HEMO HEMODYNAMIC SYSTEM DQK MCKESSON ISRAEL LTD HC12

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization
    2 57 YR