FDA Adverse Event
Malfunction
Summary report: N
JACKSON MODULAR TABLE SYSTEM
MDR report key: 883462
·
Received July 17, 2007
Report
- Report Number
- 2921578-2007-00004
- Event Type
- Malfunction
- Date Received
- July 17, 2007
- Date of Event
- May 29, 2007
- Report Date
- June 8, 2007
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
IT WAS DETERMINED DURING THE INITIAL EVALUATION THAT THE FAILURE WAS DUE TO USER ERROR BY BOTH MIZUHO ORTHOPEDIC SYSTEMS AND BY THE DIRECTOR OF SURGICAL SERVICES. MIZUHO ORTHOPEDIC SYSTEMS HAS REPEATEDLY REQUESTED A MAINTENANCE SERVICE BY PERFORMED ON THE DEVICE. THE HOSPITAL REPRESENTATIVE (TO DATE) HAS NOT RESPONDED TO THE REQUEST.
Description of Event or Problem · 1
ACCORDING TO THE MIZUHO ORTHOPEDIC SALES REPRESENTATIVE, THE HOSPITAL REPRESENTATIVE STATED, "AS THE PATIENT WAS TRANSFERRED, THE TABLE TILTED AND THE PATIENT DROPPED TO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JACKSON MODULAR TABLE SYSTEM | OPERATING ROOM TABLE | FQO | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 5803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |