BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIAC MONITOR TRANSMITTER

    MDR report key: 350540 · Received September 10, 2001

    Report

    Report Number
    350540
    Event Type
    Other
    Date Received
    September 10, 2001
    Date of Event
    July 30, 2001
    Report Date
    August 29, 2001
    Manufacturer
    AGILENT TECHNOLOGIES
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIAC MONITOR FELL APART AND HIT PT'S RIGHT GREAT TOE. CAUSED SKIN TEAR 1/2 IN DIAMETER. TRANSMITTER HAD BROKEN CLAMP AND CLAMP HAS BEEN REPLACED.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 3/6/03: MFR RECIEVED LETTER DATED DEC 23, 2002 REGARDING VOLUNTARY REPORT ON AUG 29, 2001. THE REPORT REFERENCED THE "CARDIAC MONITOR TRANSMITTER," MODEL #M2600A. THE ISSUE IDENTIFIED IN THE REPORT WAS : THE CARDIAC MONITOR FELL APART AND HIT THE PT'S RIGHT GREAT TOE. THIS CAUSED A SKIN TEAR 1/2 INCH IN DIAMETER. THE TRANSMITTER HAD A BROKEN CLAMP AND THE CLAMP HAS BEEN REPLACED. THEY ARE ADDRESSING EACH OF THE QUESTIONS IN REQUEST BY NUMBER. 1. MODEL NUMBER: M2600A VIRIDIA TELEMETRY SYSTEM. 2. SERIAL NUMBER: UNK. 3. THE CUSTOMER REPORTED THE CARDIAC MONITOR TRANSMITTER FELL APART AND INJURED THE PT'S GREAT RIGHT TOE. THE PT'S SKIN WAS TORN 1/2 INCH IN DIAMETER. THE TRANSMITTER HAD A BROKEN CLAMP, WHICH HAS BEEN REPLACED. 4. BASED ON INVESTIGATION RESULTS FROM THE HOSPTIAL BIOMED DIRECTOR, THEY FOUND THAT THE CLIP BECAME LOOSE AND BROKE OFF CAUSING THE TRANSMITTER TO FALL ON THE PT'S TOE. THE BIOMED STATED THAT THEY HAD CHECKED ALL THE TRANSMITTERS ON THE FLOOR, BUT WAS UNABLE TO DETERMINE WHICH TRANSMITTER WAS INVOLVED IN THIS INCIDENT. THE HOSPITAL DID FIND ONE DEIVCE THAT REQUIRED SOME MINOR REPAIRS AND TOOK CARE OF THE CLIP ON THAT SINGLE DEVICE. IN ADDITION, THE HOSPITAL BIOMED STATED THAT THE SERIAL NUMBER LISTED ON THE MEDWATCH WAS INACCURATE WHICH CONTRIBUTED TO THEIR INABILITY TO IDENTIFY THE ACTUAL DEVICE INVOLVED. 5. FURTHER INSPECTION OF THE CLIPS AND DEVICES DETERMINED THAT THE CLIP WAS NOT SECURED PROPERLY BY THE USER AS DOCUMENTED IN THE TELEMETRY USER MANUAL PAGE 1-8 "SECURING AND COMBINER". MINOR REPAIRS WERE MADE TO THE DEVICE AND NO FURTHER ACTION WAS NECESSARY. 6. THE DATE OF THIS EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT WAS 2001. 7. THE DATE THE FIRM RECEIVED INFO ABOUT THIS EVENT WAS SEPT 17, 2001. 8. A DEVICE WAS REPAIRED ON-SITE, HOWEVER, MFR IS UNABLE TO CONFIRM IF THE REPAIRED DEVICE WAS THE UNIT INVOLVED IN THE NOTED INCIDENT, AS STATED IN QUESTION 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40973 CARDIAC MONITOR TRANSMITTER CARDIAC MONITOR TRANSMITTER DRT AGILENT TECHNOLOGIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other