Medical Device Incident Report

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I. Incident Details:

• Date of Incident: January 15, 2050

• Time of Incident: 10:30 AM

• Location of Incident: [YOUR COMPANY NAME], Room 302

• Incident ID: MDIR-2050-001

II. Device Information:

• Device Name: MedTech Pro IV Infusion Pump

• Device Model/Serial Number: MT-IV-2050-12345

• Manufacturer: [MANUFACTURER'S NAME]

• Manufacturer Contact Information:

  • Phone: [MANUFACTURER'S NUMBER]

  • Email: [MANUFACTURER'S EMAIL]

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:

• Patient/Operator ID: PT2050-001

• Age: 58

• Sex: Female

• Medical History: Hypertension, Type 2 Diabetes

• 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:

• Conduct regular preventive maintenance checks on all medical devices to detect potential issues before they escalate.

• Provide additional training to healthcare staff on manual infusion techniques and emergency procedures in the event of device malfunctions.

• Ensure immediate availability of backup infusion pumps in clinical areas to mitigate disruptions in patient care during equipment failures.

VIII. Incident Reporting Contact:

• Reporter's Name: [YOUR NAME], RN

• Reporter's Position: Charge Nurse

• Reporter's Contact Information:

  • Phone: 423-874-6377

  • Email: [YOUR EMAIL]

IX. Approval and Review:

• Reviewed by: [PHYSICIAN'S NAME], Chief Medical Officer

• Date of Review: January 18, 2050

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[YOUR COMPANY NAME]
Address: [YOUR COMPANY ADDRESS]
Phone: [YOUR COMPANY NUMBER]
Email: [YOUR COMPANY EMAIL]
Website: [YOUR COMPANY WEBSITE]

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