FDA Adverse Event
Summary report: N
BRILLIANCE 64 AIR
MDR report key: 2861718
·
Received December 3, 2012
Report
- Report Number
- 1525965-2012-00095
- Date Received
- December 3, 2012
- Report Date
- November 7, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K012009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).
Description of Event or Problem · 1
PHILIPS RECEIVED A COMPLAINT WHERE A PATIENT WAS ON THE CT TABLE WHEN THE OPERATOR ENGAGED THE LOAD FOOT SWITCH. WHEN THE OPERATOR RELEASED THE FOOT PEDAL TO STOP THE COUCH MOTION, THE FOOT PEDAL FAILED TO DISENGAGE AND THE TABLE CONTINUED TO MOVE. THE TABLE RAISED TO CENTER FIELD OF VIEW AND CONTINUED TO DRIVE INTO THE SCANNER BORE. THE PATIENT WAS NOT HARMED. IF THIS MALFUNCTION WERE TO RECUR THERE IS POTENTIAL FOR PITCHING, ENTRAPMENT AND/OR REMOVAL OF PATIENT MEDICAL TUBING (IE VENTILATOR TUBING, IV TUBING).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRILLIANCE 64 AIR | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |