FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2102920
·
Received May 4, 2011
Report
- Report Number
- 1518293-2011-00084
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 13, 2011
- Report Date
- April 13, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER WAS NOT ABLE TO CONFIRM OR DUPLICATE REPORTED 'DEFECTS' IN PHYSICIST REPORT. FSE CHECKED THE MAXIMUM DOSE AND FOUND 9.6R/MIN IN ADULT MODE AND 4.5R/MIN IN CHILD MODE, WITHIN SPECIFICATION. FSE FOUND THE KVP TO BE ACCURATE TO (5%) IN BOTH RAD AND FLUORO MODE. FSE ALSO CHECKED THE MAS AND FOUND IT TO BE IN SPECIFICATION. FSE CHECKED AND VERIFIED THE OPERATION OF UNIT FUNCTIONS. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.
Description of Event or Problem · 1
PHYSICIST REPORTS UROLOGY SYSTEM EXCEEDING THE 10R/MIN DOES AT 30CM ABOVE TABLE TOP. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-REVERSE | UROLOGY SYSTEM | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |