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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM 7000 U (DV); SURGICAL TABLE
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM 7000 U (DV); SURGICAL TABLE Back to Search Results
Model Number 1723633
Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2019
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the operating table bounced up and down during a procedure.The investigation of this allegation is still ongoing and will be updated once a final resolution has been reached.
 
Event Description
The customer reported that the operating table bounced up and down during a procedure.No injury reported.
 
Manufacturer Narrative
Following completion of the investigation, there was no evidence that a malfunction of the trusystem 7000 dv occurred that would result in the "bouncing up and down" of the operating table.It should also be noted that the table remote in use at the time of the event was not returned with the table.As a result, it could not be ruled out as a possible contributing factor.Based on this information, no further action is required.
 
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Brand Name
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
MDR Report Key9503230
MDR Text Key196215833
Report Number3007143268-2019-00014
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 consumer
Remedial Action Notification
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
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 Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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