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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number 8098027
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Manufacturer Narrative
Siemens has initiated a technical investigation of the issue to identify the root cause.The two (2) complained bolts were re-mounted to the tabletop according to the system installation instructions.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported to siemens by the customer that the mpt-3 rtp tabletop has fallen off.According to information provided by the service engineer, two (2) of the tabletop bolts became loose over time.One (1) of the bolts fell out on an earlier date but no information is available from the customer regarding the date this happened.Siemens healthineers was not notified about this issue.The second tabletop bolt fell out on monday (b)(6) 2020 at 11:00 am.On (b)(6) 2020, after the second bolt fell out, the customer continued patient scanning but noticed that the table was starting to detach from the handle.From technical perspective the table is safe even without the two (2) bolts, because the tabletop is latched in a locking mechanism.At approximately 4:00 pm on (b)(6) 2020, the customer moved the table manually further away from the handle.This action released the locking mechanism and the tabletop fell onto the floor.There was no reported patient involvement or user injury associated with the tabletop falling on (b)(6) 2020.The user was advised to turn the scanner off and to wait for a service engineer to investigate the issue.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).
 
Manufacturer Narrative
Siemens has initiated a technical investigation of the issue to identify the root cause.The two (2) complained bolts were re-mounted to the tabletop according to the system installation instructions.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported to siemens by the customer that the mpt-3 rtp tabletop has fallen off.According to information provided by the service engineer, two (2) of the tabletop bolts became loose over time.One (1) of the bolts fell out on an earlier date but no information is available from the customer regarding the date this happened.Siemens healthineers was not notified about this issue.The second tabletop bolt fell out on monday (b)(6) 2020 at 11:00 am.On (b)(6) 2020, after the second bolt fell out, the customer continued patient scanning but noticed that the table was starting to detach from the handle.From technical perspective the table is safe even without the two (2) bolts, because the tabletop is latched in a locking mechanism.At approximately 4:00 pm on (b)(6) 2020, the customer moved the table manually further away from the handle.This action released the locking mechanism and the tabletop fell onto the floor.There was no reported patient involvement or user injury associated with the tabletop falling on (b)(6) 2020.The user was advised to turn the scanner off and to wait for a service engineer to investigate the issue.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).
 
Manufacturer Narrative
Siemens completed the technical investigation of the reported event.From technical perspective the table is safe even without the two bolts, because the tabletop is latched in a locking mechanism.It has been confirmed that the customer had moved the table without any load and manually further away from the handle.This released the locking mechanism and the tabletop fell on the floor.The two bolts were remounted by a siemens field service engineer according to the associated system instructions.The first failure (first bolt became loose) was clearly recognizable.The user should have informed the siemens service organization in case of damage or malfunction issues associated with the equipment.This warning is also described in the operator manual (print no.C2-029.620.16.03.02, page 33):"damage or defects which occur to the system (patient table, gantry), to add-ons or accessories can result in an unsafe operation.Watch out for such damage and have these parts repaired or replaced immediately." a root cause could not be determined to ascertain why the bolts became loose.According to our technical expert a similar incident has never been reported to siemens.Therefore, the issue is determined to be a single incident.No general design issue could be identified.Further action is not deemed necessary at this time.
 
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Brand Name
SOMATOM DEFINITION AS
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim, 91301
GM  91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim, 91301
GM   91301
Manufacturer Contact
rebecca tudor
40 liberty blvd.
65-1a
malvern, PA 19355
6104486484
MDR Report Key13267789
MDR Text Key285969495
Report Number3004977335-2022-10315
Device Sequence Number1
Product Code JAK
UDI-Device Identifier04056869003665
UDI-Public04056869003665
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K190578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8098027
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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