FDA Adverse Event
Malfunction
Summary report: N
ONCOR IMPRESSION
MDR report key: 1062228
·
Received June 12, 2008
Report
- Report Number
- 2910081-2008-00027
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- January 9, 2008
- Report Date
- May 21, 2008
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS
- Product Code
- IYE
- PMA / PMN Number
- K993425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
RESULTS: INVESTIGATION IS CURRENTLY PENDING AND THE ROOT CAUSE HAD NOT BEEN IDENTIFIED.
Description of Event or Problem · 1
WE ARE REPORTING THIS INCIDENT IN ABUNDANCE OF CAUTION: A PRODUCT ISSUE HAS BEEN REPORTED WITH OUR TREATMENT TABLE. WHILE THE OPERATOR WAS USING THE "HOME" FUNCTION TO OFFLOAD THE PATIENT, THE LATERAL MOVEMENT BRAKES BECOME DISENGAGED OR UNLOCKED AND POTENTIALLY CAUSE THE PATIENT TO FALL OFF THE TABLETOP. NO INJURY WAS REPORTED AS A RESULT OF THIS INCIDENT. ROOT CAUSE HAS NOT BEEN IDENTIFIED AND THE INVESTIGATION IS CURRENTLY PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONCOR IMPRESSION | MEDICAL, ACCELERATOR, LINEAR | IYE | SIEMENS MEDICAL SOLUTIONS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |