FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
MDR report key: 2800894
·
Received October 15, 2012
Report
- Report Number
- 2800894
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- October 6, 2012
- Report Date
- October 15, 2012
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- JAK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
THE STAFF RETURNED TO WORK AFTER THE WEEKEND AND REPEATEDLY RECEIVED ERROR MESSAGES ON THE SCREEN OF THE DEVICE. UPON OPENING THE PANEL ON THE DEVICE, IT WAS NOTED THE INTERNAL MECHANISMS HAD SIGNS OF HAVING CAUGHT FIRE OR OTHERWISE HAVING BURNED OVER THE WEEKEND. IT WAS ESTABLISHED THE MOST LIKELY EXPLANATION WAS THE CONDENSER LEAKED WATER ONTO THE ELECTRICAL PANEL. ACCORDING TO ONE STAFF MEMBER, THE LEAKING HAS HAPPENED ON OTHER OCCASIONS IN OTHER AREAS WITH THE SAME OR SIMILAR EQUIPMENT, AND WAS REPORTED TO THE MANUFACTURER. HOWEVER, THIS IS THE FIRST REPORT OF FIRE DAMAGE. PHOTOS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | SIEMENS MEDICAL SOLUTIONS USA, INC. | DTC | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO OTHER THERAPIES |