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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTISTE MV SYSTEM
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SIEMENS MEDICAL SOLUTIONS USA, INC. ARTISTE MV SYSTEM Back to Search Results
Model Number 08139789
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2014
Event Type  malfunction  
Event Description
Siemens was notified on (b)(6) 2014 that during a regular svc call the customer svc engineer (cse) found that the first bolt in the push-chain at the upper end of the table had backed out by 1 cm and the locking ring was gone.The cse pushed the bolt back into place and used a new locking ring to secure the bolt.There is no report of injury to pt or facility personnel.This reported issue occured in (b)(6).
 
Manufacturer Narrative
Siemens became aware of the reported issue on (b)(4) 2014.This mdr is being sent to fda via (b)(4) on 09/25/2014.Investigation is on-going and a supplemental report will be submitted upon completion.Customer address: (b)(4).
 
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Brand Name
ARTISTE MV SYSTEM
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
Manufacturer Contact
marlynne galloway
51 valley stream pkwy
ms - d02
malvern, PA 19355
6102195361
MDR Report Key4218911
MDR Text Key4996810
Report Number2910081-2014-07000
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K050422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2014
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? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received08/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
550 TXT TABLE, MAT #: 07346534, S/N: (B)(4)
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