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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
Model Number 1723633
Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
A trumpf medical service technician was dispatched to investigate this incident.It was discovered that the caldding segments had become detached, causing the restricted motion.The technician reattached the cladding segments and the table functioned as intended.
 
Event Description
A user facility reported that the cladding of a trumpf medical trusystem 7000 dv operating table fell during a case and limited the table's range of motion.No injuries were reported.
 
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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
Manufacturer Contact
steffen ulbrich
carl-zeiss strasse 7-9
saalfeld, 07318
GM   07318
MDR Report Key7647545
MDR Text Key112892777
Report Number3007143268-2018-00009
Device Sequence Number1
Product Code JEA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Remedial Action Inspection
Type of Report Initial
Report Date 06/01/2018
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 Number1723633
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/01/2018
Initial Date FDA Received06/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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