FDA Adverse Event Other Summary report: N

ADVANTX LCA

MDR report key: 1321332 · Received February 18, 2009

Report

Report Number: 9611343-2009-00009
Event Type: Other
Date Received: February 18, 2009
Date of Event: January 20, 2009
Report Date: February 18, 2009
Manufacturer: GE MEDICAL SYSTEMS SCS
Product Code: IZI
PMA / PMN Number: K945375
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: RESPIRATORY THERAPIST

Narratives

Additional Manufacturer Narrative · 1

GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT WHILE MOVING A PATIENT ONTO THE TABLE FROM A STRETCHER, THE TABLE ROTATED UNEXPECTEDLY. THE PT FELL TO THE FLOOR AND HIT THE BASE OF THE GANTRY, LANDING ON HER HEAD AND BACK. RESPIRATORY THERAPISTS WERE HELPING THE PT. NO X-RAY TECHNICIANS IN THE ROOM DURING THIS TIME. IT IS UNK WHETHER THE PT WAS SUPPORTED BY THE HEALTHCARE STAFF DURING THE TRANSFER, OR WHETHER THE STAFF WAS HOLDING THE TABLE AT THE TIME OF THE EVENT. IT IS ALSO UNK WHETHER THE TABLE WAS RETRACTED DURING THE TRANSFER. FOLLOWING THE EVENT, THE PT REPORTED HAVING A HEADACHE AND PAIN IN HER SIDE. THE PT RECEIVED A HEAD CT SCAN AND WAS OBSERVED FOR 24 HOURS. NO SIGNS OF INJURY WERE OBSERVED ON THE SCAN. THE PT WAS SENT HOME. THE EXAM WAS COMPLETED SUCCESSFULLY THE FOLLOWING DAY. GE DOES NOT SERVICE THE UNIT, HOWEVER, THE SERVICE PROVIDER CONTACTED GE FOLLOWING THE EVENT. A GE FIELD SERVICE ENGINEER (FE) COMPLETED AN INITIAL ON SITE EVALUATION. THE FE OBSERVED OXIDATION ON THE ROTATIONAL BRAKE PLATE. THE ROTATIONAL BRAKE FORCE WAS TESTED AND FOUND TO BE WITHIN SPECIFICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ADVANTX LCA	VASCULAR X-RAY SYSTEM	IZI	GE MEDICAL SYSTEMS SCS	2120637

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Hospitalization\| O