FDA Adverse Event Injury Summary report: N

TOSHIBA

MDR report key: 2485512 · Received March 9, 2012

Report

Report Number: 2020563-2012-00005
Event Type: Injury
Date Received: March 9, 2012
Date of Event: February 3, 2012
Report Date: February 10, 2012
Manufacturer: TOSHIBA MEDICAL SYSTEMS CORPORATION
Product Code: JAK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A CT EXAMINATION OF THE ABDOMEN AND CHEST WAS BEING PERFORMED ON A PATIENT. AFTER SCANOSCOPY AND SCAN PLANNING WERE PERFORMED, THE COUCH TOP WAS SLID TO THE SCAN START POSITION. AT THIS TIME, THE PATIENT'S LEFT ARM CAME INTO CONTACT WITH AN OBJECT (POSSIBLY THE GANTRY) AND AS A RESULT, WAS INJURED WITH A BONE FRACTURE OF THE LEFT ARM. A FRACTURE FIXATION PROCEDURE WAS PERFORMED FOR THE PATIENT AT THE HOSPITAL'S DEPARTMENT OF ORTHOPEDIC SURGERY. THE PATIENT IS RECOVERING. THE PATIENT HAD SUFFERED A CEREBRAL INFARCTION AND WAS UNABLE TO RAISE HER ARMS FOR THE PROCEDURE, AND WAS ON THE COUCH TOP WITH HER RIGHT ARM PLACED ON HER ABDOMEN AND HER LEFT ARM PLACED AT HER SIDE. IMMOBILIZATION BANDS WERE NOT USED. THE PATIENT'S LEFT ARM WAS NOT EASILY VISIBLE TO THE OPERATOR. IT IS CONSIDERED THAT THE PATIENT'S LEFT ARM WAS EXTENDED AND HUNG OVER THE COUCH TOP. THE CT SYSTEM IS WORKING NORMALLY FOLLOWING THE EVENT. WE BELIEVE THAT THE CAUSE OF THE INCIDENT IS USER ERROR. THE SAFETY WARNING AND PRECAUTIONS WERE NOT FOLLOWED IN THE OPERATION MANUAL.

Description of Event or Problem · 1

DURING COUCH TOP SLIDING, A PATIENT'S LEFT ARM CAME IN CONTACT WITH AN OBJECT (POSSIBLE THE GANTRY) AND AS A RESULT, WAS INJURED WITH A BONE FRACTURE TO THE LEFT ARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TOSHIBA	COMPUTED TOMOGRAPHY SYSTEM	JAK	TOSHIBA MEDICAL SYSTEMS CORPORATION	TSX-101A/EI

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Other