FDA Adverse Event
Other
Summary report: N
5943API ADVANCED CONTROL PADS
MDR report key: 1025912
·
Received April 4, 2008
Report
- Report Number
- 2921578-2008-00009
- Event Type
- Other
- Date Received
- April 4, 2008
- Date of Event
- January 16, 2008
- Report Date
- March 1, 2008
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- FWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FOUND THE END-USER INAPPROPRIATELY POSITIONING THE PLACEMENT AND USING THE WRONG SIZE PADS. THEY WERE ALSO INAPPROPRIATELY POSITIONING THE PT ON THE PADS AND TABLE. IT WAS ALSO DETERMINED THAT THE HOSPITAL WAS NOT USING THE PT CARE KIT TO REDUCE ABRASIONS AND STICTION OF THE PT ON THE PADS. AN INSERVICE WITH THE HOSP HAS BEEN REQUESTED.
Description of Event or Problem · 1
AFTER A FOUR HR SURGERY, THE PT'S SKIN WAS BREAKING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5943API ADVANCED CONTROL PADS | MODULAR OPERATING ROOM TABLE | FWY | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 5943API |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other | JST SPINAL TABLE| 5803 ADVANCED CONTROL BASE |