FDA Adverse Event
Death
Summary report: N
MAQUET O.R. TABLE SYSTEM MAGNUS
MDR report key: 3721987
·
Received March 25, 2014
Report
- Report Number
- 3008355164-2014-00069
- Event Type
- Death
- Date Received
- March 25, 2014
- Report Date
- February 24, 2014
- Manufacturer
- MAQUET GMBH
- Product Code
- FQO
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED TO MAQUET THAT THEY ARE DISSATISFIED WITH THE IMAGE QUALITY AND SYSTEM CONTROLS OF THE MAQUET MAGNUS HYBRID TABLE SYSTEM INSTALLED AT THEIR HOSPITAL. MAQUET AGREED TO REMOVE THE MAGNUS TABLE SYSTEM FROM THE HOSPITAL AS IT DID NOT MEET THEIR NEEDS. DURING THE CONVERSATION OUTLINING THE REMOVAL PLAN; A HOSPITAL REP INFORMED MAQUET THAT THERE WAS A DEATH IN THE ROOM CONTAINING THE MAGNUS TABLE. THE CUSTOMER DID NOT DIRECTLY INDICATE IF THE ALLEGED DEATH WAS ATTRIBUTED TO THE MAGNUS DEVICE. ONLY THE HEIGHT AND WEIGHT DATA OF THE PT WAS REPORTED TO MAQUET. HEIGHT 5'10" AND WEIGHT 210 POUNDS. (B)(4). REF MFR # 80100652-2014-00007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173768 | MAQUET O.R. TABLE SYSTEM MAGNUS | FQO & KXJ-TABLE,AC POWERED & RADIOLOGIC | FQO | MAQUET GMBH | 1180.01B1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Death |