MAINFRAME 8252001IP RESPONSE 2.0 W/INCRE
Report
- Report Number
- 1045254-2013-00015
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Report Date
- December 6, 2012
- Manufacturer
- XOMED MFG JACKSONVILLE
- Product Code
- ETN
- PMA / PMN Number
- K024316
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ANALYSIS WAS COMPLETED. THE UNITS WERE EVALUATED AND FOUND THE CPU BATTERY REQUIRED REPLACEMENT. THE STIMULATION CONTROL BOARD WAS BAD AND REQUIRED REPLACEMENT. BOTH COMPONENTS RECEIVED PREVENTATIVE MAINTENANCE AND WERE TESTED TO SPECIFICATION, AND RETURNED TO THE CUSTOMER. THE COMPLAINT WAS CONFIRMED AND FOUND TO BE OUT OF SPECIFICATION.
THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. EVALUATION, METHOD: NO TESTING METHODS PERFORMED. EVALUATION, RESULT : NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION - DEVICE NOT RETURNED - NO EVALUATION WILL BE PERFORMED.
PRODUCT WAS RETURNED FOR ANALYSIS ON (B)(4) 2012. PRODUCT # 8252800, INTERFACE RESPONSE 2.0 INCREMENT WAS ALSO RETURNED FOR EVALUATION. ANALYSIS FOUND A BLOWN FUSE.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THERE WAS NO STIM RETURN. THERE WAS NO REPORTED PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5386 | MAINFRAME 8252001IP RESPONSE 2.0 W/INCRE | STIMULATOR, NERVE | ETN | XOMED MFG JACKSONVILLE | 8252001IP | 59899800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |