FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 1112782
·
Received August 12, 2008
Report
- Report Number
- 1518293-2008-00258
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 1, 2008
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER MEASURED FLUORO DOSE PER CHAPTER 2.7 OF THE SERVICE MANUAL WITH RAD CHECK PLUS, CALIBRATION DATE 2008. READING OBTAINED WAS 9.4 R/MIN WHICH IS WITHIN SPECIFICATION. SYSTEM WAS ALSO CHECKED BY HOSPITAL'S BIO-MED WITH THE HOSPITAL'S TEST EQUIPMENT AND THE READING WAS 9.88 R /MIN. FSE CALLED AND TALKED WITH TESTING PHYSICIST WITH ALLIANCE MEDICAL PHYSICS. THEY WERE NOT SURE WHAT THE READING WAS AT THIS TIME AND SAID TO DOCUMENT LF FSE FINDINGS AND GIVE THEM TO FACILITY BIOMED. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.
Description of Event or Problem · 1
PHYSICIST REPORTS ENTRANCE DOSE TO HIGH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-REVERSE | UROLOGY SUITE | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |