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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG MOBILE COLUMN TRUSYSTEM 7500; SURGICAL TABLE
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG MOBILE COLUMN TRUSYSTEM 7500; SURGICAL TABLE Back to Search Results
Model Number 1717023
Device Problems Mechanical Problem (1384); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2019
Event Type  malfunction  
Manufacturer Narrative
The operating table was investigated by a service technician.No malfunction or defect was identified.The device operated as intended.The remote control was exchanged as a preventive action.Based on this information, no further action is required.
 
Event Description
During surgery, the table top and column moved into the reflex position without a command from the remote control.No patient or caregiver injury was reported.
 
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Brand Name
MOBILE COLUMN TRUSYSTEM 7500
Type of Device
SURGICAL TABLE
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 Key8776601
MDR Text Key150751651
Report Number3007143268-2019-00009
Device Sequence Number1
Product Code JEA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1717023
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2014
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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