Medical Device Incident Report
Medical Device Incident Report
I. Incident Details:
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Date of Incident: January 15, 2050
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Time of Incident: 10:30 AM
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Location of Incident: [YOUR COMPANY NAME], Room 302
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Incident ID: MDIR-2050-001
II. Device Information:
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Device Name: MedTech Pro IV Infusion Pump
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Device Model/Serial Number: MT-IV-2050-12345
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Manufacturer: [MANUFACTURER'S NAME]
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Manufacturer Contact Information:
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Phone: [MANUFACTURER'S NUMBER]
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Email: [MANUFACTURER'S EMAIL]
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III. Description of Incident:
The MedTech Pro IV Infusion Pump experienced a sudden malfunction during a patient's intravenous therapy session. The device displayed an error message indicating "Pump Failure" and ceased delivering fluids to the patient. As a result, the patient experienced a brief interruption in medication delivery, causing concern among the attending healthcare staff.
IV. Patient/Operator Information:
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Patient/Operator ID: PT2050-001
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Age: 58
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Sex: Female
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Medical History: Hypertension, Type 2 Diabetes
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Role/Position (if Operator): Registered Nurse
V. Actions Taken:
Upon encountering the error message, the attending nurse immediately notified the charge nurse and initiated a manual infusion to ensure the patient continued to receive medication. The charge nurse contacted the biomedical engineering department to request a service technician to inspect and troubleshoot the malfunctioning device.
VI. Follow-Up Actions:
The biomedical engineering department has scheduled a maintenance check on the MedTech Pro IV Infusion Pump to identify the root cause of the malfunction. Additionally, a report detailing the incident will be submitted to the hospital's quality management team for further investigation and documentation.
VII. Recommendations:
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Conduct regular preventive maintenance checks on all medical devices to detect potential issues before they escalate.
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Provide additional training to healthcare staff on manual infusion techniques and emergency procedures in the event of device malfunctions.
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Ensure immediate availability of backup infusion pumps in clinical areas to mitigate disruptions in patient care during equipment failures.
VIII. Incident Reporting Contact:
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Reporter's Name: [YOUR NAME], RN
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Reporter's Position: Charge Nurse
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Reporter's Contact Information:
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Phone: 423-874-6377
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Email: [YOUR EMAIL]
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IX. Approval and Review:
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Reviewed by: [PHYSICIAN'S NAME], Chief Medical Officer
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Date of Review: January 18, 2050
[YOUR COMPANY NAME]
Address: [YOUR COMPANY ADDRESS]
Phone: [YOUR COMPANY NUMBER]
Email: [YOUR COMPANY EMAIL]
Website: [YOUR COMPANY WEBSITE]
