FDA Adverse Event Injury Summary report: N

MAMMOMAT INSPIRATION

MDR report key: 2389164 · Received December 15, 2011

Report

Report Number: 2240869-2011-00049
Event Type: Injury
Date Received: December 15, 2011
Date of Event: November 21, 2011
Report Date: December 14, 2011
Manufacturer: SIEMENS AG
Product Code: MUE
PMA / PMN Number: P030010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED SYSTEM IS WORKING WITHIN SPECS. THE RISK OF COLLISION AND CRUSHING IS DESCRIBED IN THE OPERATOR MANUAL FOR MAMMOMAT INSPIRATION (B)(4) IN CHAPTER "PERSONAL SAFETY". POSSIBLE DANGER ZONES ARE MARKED. ALSO, A WARNING FOR DANGER OF CRUSHING AND JAMMING OF BODY PARTS BY MOTOR-DRIVEN SYSTEM MOVEMENTS IS INCLUDED IN THE OPERATOR MANUAL. PMA P030010/S6.

Description of Event or Problem · 1

IT WAS REPORTED THAT A TECHNICIAN WAS ASSISTING IMAGING A PT IN A WHEELCHAIR. TUBE ARM WAS ROTATED TO 80 DEGREES. ASSISTANT WAS PRESENT IN THE ROOM TO HELP DURING THE EXAM. THE ASSISTANT WAS USING THE SWIVEL-ARM OPERATION KEY THAT WAS FACING UPWARD. THE TECHNICIAN WAS BELOW THE SWIVEL ARM POSITIONING THE PT WHEN THE CONTROL PANEL ON THE TUBE ARM CAME IN CONTACT WITH HER SHOULDER/UPPER ARM AREA. THE BUTTON TO LOWER THE TUBE ARM GOT ACTIVATED BY THIS ACCIDENTAL CONTACT CAUSING THE TUBE ARM TO COMPRESS THE TECHNICIAN'S ARM. THE ASSISTANT HAD TO PRESS THE EMERGENCY STOP BUTTON AND THE TECHNICIAN WAS RELEASED. THE EXAM OF THE PT WAS COMPLETED WITHOUT FURTHER INCIDENTS. SIEMENS LOCAL SERVICE ENGINEER, (B)(6), CONFIRMED THAT THE REPORTED EVENT CAUSED BRUISING AND MUSCLE STRAIN OF THE RIGHT SHOULDER AND UPPER ARM OF THE TECHNICIAN. THE TECHNICIAN WAS TREATED WITH PAIN MEDICATION AND PHYSICAL THERAPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAMMOMAT INSPIRATION	FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAM	MUE	SIEMENS AG	10140000

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other