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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM 7000 DV
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM 7000 DV Back to Search Results
Catalog Number 1723633
Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
A trumpf medical technician inspected the surgical table and was not able to duplicate the failure.The error logs were obtained for further evaluation.A follow-up report will be submitted once new information is available.
 
Event Description
A user facility reported that a trusystem 7000 dv surgical table stopped working while in trendelenburg position.There were no injuries reported.
 
Manufacturer Narrative
The table logs were evaluated and the root cause was determined to be a software error that led to the table not identifying a drive motor failure.When the user requested table movement, the table failed to give notice of the motor failure and did not respond to the input.Recurrence of this malfunction is very unlikely due to the specific conditions that led to the failure.A software change is currently in process to resolve the issue.Based on this information, no further action is required.
 
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Brand Name
TRUSYSTEM 7000 DV
Type of Device
7000 DV
Manufacturer (Section D)
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
carl-zeiss strasse 7-9
saalfeld, 07318
GM  07318
MDR Report Key7447449
MDR Text Key106390980
Report Number3007143268-2018-00003
Device Sequence Number1
Product Code JEA
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Repair
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1723633
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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