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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS GMBH MEDICAL SOLUTIONS ARTUSTE NV SYSTEM

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SIEMENS GMBH MEDICAL SOLUTIONS ARTUSTE NV SYSTEM Back to Search Results
Model Number 08139789
Device Problems Break (1069); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2015
Event Type  malfunction  
Event Description
Siemens became aware on (b)(6) 2015 that the chain master linker was broken during gantry rotation.As a consequence, the actuator ram was also broken due to the open chain with loose ends when the gantry rotation continued.There is no report of injury to a patient or facility personnel.This reported incident occurred in (b)(6).
 
Manufacturer Narrative
Investigation showed that the material of the complaint part was too soft and not as specified and parts from service stock also fail to meet the specification.However, the tensile test of the chain-actuator combination and the calculated proof of safety showed that the parts used are strong enough for usage with the system, including the softer material of the actuator.Specifications for the chain-actuator combination (associated parts used) and the relevant maintenance instructions will be updated.
 
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Brand Name
ARTUSTE NV SYSTEM
Manufacturer (Section D)
SIEMENS GMBH MEDICAL SOLUTIONS
roentgenstrasse 19021
kemnath 95478
GM  95478
Manufacturer Contact
marlynee galloway
51 valley stream pkwy.
ms - d02
malvern, PA 19355-1406
6102195361
MDR Report Key4834675
MDR Text Key5943641
Report Number2240869-2015-02433
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K090783
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,company representati
Reporter Occupation Unknown
Type of Report Initial,Followup
Report Date 05/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number08139789
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/08/2015
Initial Date FDA Received06/05/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/08/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CHAIN MASTER LINKER; ACTUATOR RAM
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