FDA Adverse Event Malfunction Summary report: N

SIEMENS DIACAM

MDR report key: 515875 · Received March 2, 2004

Report

Report Number
MW1031399
Event Type
Malfunction
Date Received
March 2, 2004
Date of Event
October 15, 2003
Report Date
February 26, 2004
Manufacturer
SIEMENS
Product Code
IYX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
RESPIRATORY THERAPIST

Narratives

Description of Event or Problem · 1

FACILITY HAS BEEN FIGHTING SIEMENS TO GET SOMEONE THERE TO REPAIR NUCLEAR MEDICINE CAMERA. THE ISSUE BEGAN WITH SIEMENS SERVICE WAY BACK IN OCT OF 2003. AT THAT TIME, FACILITY CALLED IN A PROBLEM WITH POOR FLOOD RESULTS. IT WAS DETERMINED THAT THE PROBLEM WAS RELATED TO THE X-Y COORDINATES ON THE FLOOD. SIEMENS UPTIME WAS CONTACTED. ON THIS OCCASION THERE WHERE 3 MISSED SERVICE APPOINTMENTS, 9 DOWN DAYS, AND 5 SEPARATE SERVICE VISTS BEFORE FACILITY WAS UP AND RUNNING. LAST YEAR FACILITY HAD A SIEMENS SERVICE PERSON CRASH THE HARD DRIVE ON THE APPLE COMPUTER THAT IS PART OF THE CAMERA. THIS PERSON WANTED TO INSTALL A "PATCH" INTO SYSTEM. FACILITY FOUND OUT LATER THAT THIS WAS JUST A SOFTWARE LOCK THAT IS PUT ON COMPUTER TO PREVENT 3RD PARTY SERVICE PERSONNEL FROM WORKING ON THE EQUIPMENT. FACILITY AGAIN HAD A POOR FLOOD PROBLEM (JUST 4 MONTHS AFTER THE PREVIOUS PROBLEM). THIS TIME IT APPEARED THAT THE SIEMENS SERVICE PEOPLE WERE READING FROM A SCRIPT FROM THE PREVIOUS SERVICE CALL. AGAIN HAD SEVERAL MISSED APPOINTMENTS FROM SIEMENS SERVICE PERSONNEL, AND FACILITY'S NOW AT THE TIME OF THIS LETTER, AT 23 DOWN DAYS AND COUNTING. THE PROBLEMS FOUND ARE AS FOLLOWS" 1. TUBE GAINS RANGE FROM FLAT (60 TO 150) TO 70 KEV NORMAL PEAK TO 155 KEV ON INDIVIDUAL TUBES WITH THE CORRECTIONS TURNED OFF. 2. THE CENTERING IS PART OF THE PROBLEM BUT CANNOT BE ADJUSTED UNTIL ALL THE TUBES ARE IN WORKING ORDER IN THE NORMAL RANGE 140+/- 10% AND THE OTHER PROBLEMS ARE RESOLVED. 3. PCALC FAILS DATA TESTS. THIS IS A PROBLEM BUT IS NOT THE CAUSE OF THE MAJOR PROBLEMS. 4. NUMBEROUS PRE-AMPS WERE CHANGED AND ALSO THE PI59 WAS REPLACED BY SIEMENS. 5. IF ONE GOES INTO THE HEAD AND ATTEMPTS TO REPAIR THE HEAD IT WOULD INVALIDATE THE WARRANTEE ON THE EXPENSIVE PARTS ALREADY REPLACED BY SIEMENS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SIEMENS DIACAM NUCLEAR MEDICINE CAMERA IYX SIEMENS HD3 INTIGRATED *

Patients

Seq Age Sex Outcome Treatment
1 * Other