FDA Adverse Event
Malfunction
Summary report: N
MULTI DIAGNOST 4
MDR report key: 1912489
·
Received November 22, 2010
Report
- Report Number
- 3003768277-2010-00325
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 28, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- JAA
- PMA / PMN Number
- K961374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(CONCLUSIONS) - THE INVESTIGATION FOUND THE NEAR TABLE CONTROLLER CABLE HAD SHORTED TO THE CONTROL BOX CAUSING THE UNEXPECTED MOVEMENT OF THE TABLETOP CRADLE. THIS IS THE FIRST REPORT OF SUCH A FAILURE. THERE IS NO STRUCTURAL PROBLEM AND NO NEED FOR ANY MANDATORY FIELD ACTION. (B)(4).
Description of Event or Problem · 1
THIS X-RAY SYSTEM'S TABLETOP CRADLE ROTATED WITH THE PT ON THE TABLE. THERE WAS NO OPERATOR CONTROL SELECTED AT THIS TIME. THE EMERGENCY STOP BUTTON WAS ACTIVATED TO KEEP THE PT FROM FALLING OFF THE TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI DIAGNOST 4 | JAA (X-RAY FLUOROSCOPIC, IMAGE-INTENSIFIED, SYSTEM) | JAA | PHILIPS MEDICAL SYSTEMS | 708031 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |