FDA Adverse Event Malfunction Summary report: N

E.COM, SYMBIA E

MDR report key: 2511533 · Received March 15, 2012

Report

Report Number: 1423253-2012-00001
Event Type: Malfunction
Date Received: March 15, 2012
Date of Event: February 23, 2012
Report Date: February 24, 2012
Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP
Product Code: IYX
PMA / PMN Number: K992731
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AFFECTED MODEL NUMBERS: 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823946, 07823953, 07823979, 10151531, 10151532, 10275879, 10413009, 10520745. THERE ARE THREE (3) APPLICABLE 510 (K): E.CAM: K992731, SYMBIA E SINGLE/DUAL: K0782506, K082506.

Description of Event or Problem · 1

THE FOLLOWING PRODUCT PROBLEMS WAS FOUND. THERE ARE NO INJURY REPORTS RECEIVED. FOR E. CAM AND SYMBIA E SYSTEMS THAT HAVE HAD EITHER THE MOTOR ASSEMBLY OR MOTOR REPLACED, THE POSSIBILITY EXISTS THAT THE RADIAL DRIVE SHAFT GEAR MAY HAVE BEEN REPLACED INCORRECTLY. THE DETECTOR MUST BE POSITIONED ABOVE/OBLIQUELY AROUND THE PT WITHOUT CLEARANCE TO REMOVE THE PT BY PULLING THE PTS OUT WHEN A FAILURE OCCURS. REMOVING THE PT PREVENTS INJURY. THE PROBABILITY IS LIMITED TO THOSE SYSTEMS THAT HAVE HAD THE MOTOR ASSEMBLY OR MOTOR REPLACED IN THE FIELD AND THAT WHEN THE REPLACEMENT OCCURRED, THE SVC ENGINEER REPLACED THE RADIAL DRIVE SHAFT GEAR BACKWARDS. SYSTEMS THAT HAVE NOT HAD THE RADIAL DRIVE SHAFT GEAR REPLACED IN THE FIELD ARE NOT AFFECTED. THE RADIAL DRIVE SHAFT GEAR ASSEMBLY IS CORRECT IN MFG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	E.COM, SYMBIA E	GAMMA CAMERA	IYX	SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP	04380213

Patients

Seq	Age	Sex	Outcome	Treatment
1