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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U (DV); SURGICAL TABLE
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U (DV); SURGICAL TABLE Back to Search Results
Model Number 1723633
Device Problems Mechanical Problem (1384); Unintended Movement (3026); Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
A trumpf medical service technician was dispatched to inspect the operating table.During the inspection, no malfunction or defect was identified, and the device operated as intended.Based on this information, no further action is required.
 
Event Description
The customer reported that the head section fell from the table and the patient's head dropped.No injury was reported.
 
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Brand Name
OPERATING TABLE TRUSYSTEM 7000 U (DV)
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 Key8808501
MDR Text Key151626194
Report Number3007143268-2019-00010
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
Reporter Occupation Administrator/Supervisor
Remedial Action Inspection
Type of Report Initial
Report Date 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
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
Date Manufacturer Received06/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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