Table 2.

Harm described in 43 events

Harm	Generic device	n	Examples
Additional exposure to X-rays	Mammography (n = 19), CT (n = 4)	23	Scans aborting mid-procedure, cutoff images, or images with artifacts, breast compression plate releasing during image-guided biopsy procedures, required scans to be repeated. In one event X-ray exposure did not stop and had to be manually interrupted.
Radiation treatment delivered to incorrect location	Radiotherapy planning	3	(1) Two users inadvertently altered the planning target volume and radiation was delivered outside the intended treatment target. (2) One patient’s position was not correctly calibrated resulting in a 1 cm discrepancy with the radiotherapy plan.
Struck by moving machinery	Mammography	3	Patients were struck by uncommanded movement of scanner c-arms.
Death	Ultrasound (n = 1), insulin dosing (n = 1)	2	See Box 1
Mispositioned surgical screws	Computer-assisted surgical device	2	Pedicle screws were mispositioned during computer guided surgery. (1) One was attributed to use error possibly due to the trajectory of the pak needle being altered while advancing through soft tissue, causing the navigation system to show a different to actual trajectory. (2) Inaccurate positioning caused the left side of the patients L4 pedicle to be breached, the device was reported to be working within specifications.
Radiation treatment overdose	Radiotherapy planning	2	(1) Caused by the electron calibration curve being incorrectly defined as absolute density resulting in 7 patients receiving higher than intended radiation doses. (2) Manual override caused the patient to be modeled as water leading to a 10% radiation overdose to be delivered.
Movement of machinery during biopsy procedure	Mammography	2	(1) The device lost the target, and the clinician manually moved the needle, resulting in the patient fainting, a 1 cm cut that required suturing and the biopsy not being obtained. (2) The c-arm unexpectedly began to rotate resulting in discomfort, bruising and failure to place the biopsy marker.
Hypoglycemia	Insulin dosing	1	User administered insulin but not the carbohydrate recommended by the device resulting in hypoglycemia.
Device results caused user to delay seeking emergency medical care	EKG	1	See Box 4
Mispositioned biopsy tags	Mammography	1	Incorrectly entered data resulted in biopsy markers being placed in an incorrect location which then had to be surgically removed.
Panic attacked/anxiety from false-positive result	EKG	1	Patient experienced panic attack and anxiety from a false-positive interpretation of atrial fibrillation from a consumer EKG device.
Unplanned pregnancy	Fertility/contraceptive software	1	Consumer became pregnant while using a contraceptive app, the pregnancy was aborted.
Electric shock	Mammography	1	Patient felt electric shock during mammogram but did not require medical treatment.