MAINFRAME 8253001 NIM RESPONSE 3.0
Report
- Report Number
- 1045254-2013-00504
- Event Type
- Malfunction
- Date Received
- August 28, 2013
- Date of Event
- July 30, 2013
- Report Date
- August 13, 2013
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- ETN
- PMA / PMN Number
- K083124
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: 8253200 - PATIENT INTERFACE; 8253200 RESPONSE 3.0, S/N (B)(4), LOT 205640133, 510K: K083124, ETN MANUFACTURED 1-5-2012 8229307 - ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE, S/N AND LOT NOT AVAILABLE, 510K: K925640, ETN. (B)(4). PRODUCT EVALUATION: RECEIVED NIM 3.0 MAINFRAME AND INTERFACE FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICE SHOWED THAT THE MAINF RAME WAS MISSING A RUBBER FOOT AND THE WAVE WASHERS IN THE INTERFACE¿S CLIPS WERE WORN; HOWEVER, THESE ARE EXTERNAL MECHANICAL PARTS THAT DO NOT AFFECT THE UNITS¿ FUNCTIONALITY. THE INTERFACE AND SIMULATOR WERE CONNECTED AND THE MAINFRAME TURNED ON; BOOT-UP SEQUENCE COMPLETED WITH NO ERRORS. TOUCHSCREEN RESPONDED. A MONITORING MODE WAS SELECTED USING ALL AVAILABLE CHANNELS. EACH CHANNEL WAS STIMULATED IN TURN; NORMAL AND APPROPRIATE RESPONSES WERE SEEN ON ALL CHANNELS. ELECTRODE CHECK WAS WITHIN ACCEPTABLE RANGES FOR ALL CHANNELS, STIM 1 AND 2, AND GROUND. SERVICE AND REPAIR COULD NOT VERIFY CUSTOMER'S ISSUE WITH THE MAINFRAME (8253001). THE UNIT HAD THE OLD SOFTWARE; REPLACED CF CARD TO UPGRADE SOFTWARE AND INSTALLED MISSING FEET RIVET. AS A PRECAUTIONARY MEASURE, PLACED UNIT IN BURN-IN FOR 4 HOURS ATTEMPTING TO OBSERVE ANY HEAT RELATED FAILURE. UNIT NEVER FAILED. UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. SERVICE AND REPAIR COULD NOT DUPLICATE CUSTOMER¿S COMPLAINT WITH THE INTERFACE (8253200), HOWEVER, THIS PATIENT INTERFACE CABLE CAME IN WITH THE BACK CLIP LOOSE; REPLACED THE WASHER ON THE CLIPS. THE ITEM WAS CLEANED, TESTED AND PASSED ALL MAN UFACTURING SPECIFICATIONS. THE EMG TUBE (8229307) WILL NOT BE EVALUATED; IT WAS DISCARDED AFTER THE PROCEDURE. THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED NOR CONFIRMED. PER THE INSTRUCTIONS FOR USE FOR THE EMG TUBE (8229307): ¿ AVOID DAMAGE TO THE TRACHEA, LARYNX OR VOCAL CORDS DURING INSERTION BY INSPECTING THE TUBE, CUFF, AND MONITORING CONNECTIONS FOR DAMAGE, WHICH MAY OCCUR IF THE CUFF IS OVER INFLATED DURING SET-UP TESTING. AVOID FALSE NEGATIVE RESPONSES (FAILURE TO LOCATE NERVE), WHICH MAY BE CAUSED BY: ¿ NEUROMUSCULAR FATIGUE FROM PROLONGED OR REPEATED EXPOSURE TO ELECTRICAL STIMULI. ¿ DEEP ANESTHESIA, WHICH MAY SUPPRESS NEUROELECTRICAL ACTIVITY OF THE RECURRENT LARYNGEAL NERVE. ¿ INSUFFICIENT CONTACT BETWEEN THE ELECTRODES AND VOCAL CORDS DUE TO MISPLACEMENT OR USING A TUBE SIZE THAT IS TOO SMALL. ¿ DISPLACEMENT DURING THE PROCEDURE WHEN ROTATING THE PATIENT¿S HEAD AND NECK. THE PROPER SIZE TUBE FOR THE INDIVIDUAL PATIENT SHOULD BE DETERMINED PRIOR TO INTUBATION BY THE ANESTHESIA PROVIDER AND/OR SURGEON. A TUBE THAT IS ONE SIZE LARGER THAN STANDARD SELECTION IS RECOMMENDED WHENEVER POSSIBLE TO IMPROVE ELECTRODE CONTACT WITH VOCAL CORDS.
IT WAS REPORTED THAT THE NERVE JUMPED IN THE CASE, BUT NOT ON THE MACHINE. IT WAS CLARIFIED THAT DURING A THYROIDECTOMY THE PHYSICIAN NOTED THAT WHEN STIMULATING THE RIGHT SIDE HE COULD SEE THE NERVE REACT AND JUMP, BUT THERE WAS NO RESPONSE ON THE MONITOR SCREEN. THE LEFT SIDE WORKED AS EXPECTED. THE PATIENT HAD MILD WEAKNESS OF HER VOICE AFTER THE PROCEDURE; SHE HAS YET TO RETURN FOR HER FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423337 | MAINFRAME 8253001 NIM RESPONSE 3.0 | STIMULATOR, NERVE | ETN | MEDTRONIC XOMED, INC. | 8253001 | 1NR3-1298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR |