Medical Device Incident Report
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:
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
[YOUR COMPANY NAME]
Address: [YOUR COMPANY ADDRESS]
Phone: [YOUR COMPANY NUMBER]
Email: [YOUR COMPANY EMAIL]
Website: [YOUR COMPANY WEBSITE]
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