Tips to Remember When a Medical Device Adverse Event Happens
MedSun: Newsletter #39, August 2009

(Excerpted with permission from the University of Michigan Health System Risk Management Handbook 2008)
Jahan Azizi, Clinical Engineer for Risk Management, U. of Mich. Hosp. Sys, Bill Riemenschneider and Suzanne Rich, MedSun


After assessing the safety and well-being of the patient, patient's visitors, and staff:


• If a patient or staff is involved, notify the patient’s physician(s), your manager or supervisor, and Risk Management, according to your facility’s protocol.
• Don’t unplug or turn off equipment unless it poses a danger to the patient – unplugging or turning off devices can cause important or useful stored data to be lost. This data is often critical to understanding what happened.
• Submit a report, according to your hospital’s policy and procedure (e.g., via phone, online, or by submitting a hardcopy incident event report).

1. State exactly what happened during the event by documenting all details
related to the event. Include in your event assessment:

• Actions taken to address the situation, including notification of primary care providers and nursing, biomedical and risk management supervisors as appropriate.
• Any associated injuries to the patient, visitors, or staff, follow-up care taken, and outcome.
• Provide information on the types of tests that were done to mitigate the effects of the event. Don’t include tests that were done as a part of the patient’s original treatment.
• For example, if an X-ray was taken in order to locate a fragment of a broken device.
• If a biomedical staff person or manufacturer’s service representative performed an analysis of a failed instrument, provide the date and time of the analysis and the results.

2. Provide device identifier information including manufacturer, brand, model, lot and serial number information if available. If the event involves a disposable device that was discarded, obtain device identifier information from product in stock.

• Provide device identifier information for the whole “device system”. For example, a report describing erroneous readings from a pulse oximeter may need to include information on the monitor and cables used with the pulse oximeter if it isn’t clear the problem is strictly with the finger sensor.


Save and Tag the medical devices and equipment involved, including disposable items and packaging (e.g., foley catheters, IV pumps and tubing, etc.).

1. Use your facility’s tag or use the sample below as a critical safety step to prevent further use of the device or equipment on a patient.
2. Sequestering the devices and equipment provides for evaluation by biomedical or clinical engineering or by the manufacturer and preserves historical data helpful to understanding the role of the device in the event.

Defective Medical Device Tag


MedSun Newsletters are available at www.fda.gov/cdrh/medsun