FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 2142090
·
Received May 24, 2011
Report
- Report Number
- 1518293-2011-00097
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 17, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER CONFIRMED AN ECAL ERROR ON THE COLLIMATOR AND ASSISTED THE CUSTOMER IN ITS REPLACEMENT USING SERVICE MANUAL 710951. AN ECAL ERROR, ON THIS COLLIMATOR MEANS THAT ONE OF THE COLLIMATOR MOTORS WAS NOT FUNCTIONING. IN THIS EVENT, THE HUT SYSTEM IS DESIGNED TO PRODUCE A SAFETY INTERLOCK ON THE SEDECAL GENERATOR TO PREVENT X-RAY. FSE VERIFIED PROPER OPERATION OF THE UNIT PER THE SERVICE CHECKLIST AND UNIT RETURNED TO FULL SERVICE BY THE CUSTOMER.
Description of Event or Problem · 1
ON (B)(6) 2011: CUSTOMER REPORTS THAT DURING AN UNDETERMINED UROLOGY PROCEDURE THE SYSTEM FLUORO FAILED. STAFF MOVED THE PATIENT TO ANOTHER ROOM, WHERE PROCEDURE WAS COMPLETED BY PHYSICIAN WITHOUT FURTHER INCIDENT. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-STANDARD | UROLOGY SUITE | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |