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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET GMBH MAGNUS OPERATING TABLE SYSTEM; TABLE, OPERATING-ROOM, AC-POWERED

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MAQUET GMBH MAGNUS OPERATING TABLE SYSTEM; TABLE, OPERATING-ROOM, AC-POWERED Back to Search Results
Model Number 118001B4
Medical Device Problem Code Device Sensing Problem (2917)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/02/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 event site postal code: (b)(6).E1 event site name: (b)(6) hospital.E1 event site address: (b)(6).
 
Event or Problem Description
Getinge became aware of an issue with one of our table 118001b4 - hybrid or table column, surface-mounted.As it was stated, during the surgery the dsa reported an error, the operating table moved slowly, and 3d imaging was impossible.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, the inability to position the table as required during the procedure, was to reoccur.
 
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Brand Name
MAGNUS OPERATING TABLE SYSTEM
Common Device Name
TABLE, OPERATING-ROOM, AC-POWERED
Manufacturer (Section D)
MAQUET GMBH
kehler strasse 31
rastatt
GM 
Manufacturer (Section G)
MAQUET GMBH
kehler strasse 31
rastatt
GM  
Manufacturer Contact
holger ullrich
kehler strasse 31
rastatt 
GM  
MDR Report Key24697364
Report Number8010652-2026-0000032
Device Sequence Number10151796
Product Code FQO
UDI-Device Identifier04046768124752
UDI-Public(01)04046768124752(11)220203
Combination Product (Y/N)N
Initial Reporter CountryCH
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,User Facility,Company Representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/26/2026
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 Model Number118001B4
Device Catalogue Number118001B4
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2026
Initial Report FDA Received Date03/26/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/03/2022
Is the Device Labeled for Single Use? (Y/N) No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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