NEUROSIGN
Report
- Report Number
- 8021774-2021-00009
- Event Type
- Malfunction
- Date Received
- July 9, 2021
- Date of Event
- June 11, 2021
- Report Date
- January 28, 2022
- Manufacturer
- THE MAGSTIM COMPANY LIMITED
- Product Code
- ETN
- PMA / PMN Number
- K203684
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIALLY A VISIT OUT TO ACCESS THE DEVICE WAS SCHEDULED BY THE E SERVICES (DISTRIBUTER) IN CHILE BUT HAD TO BE CANCELLED DUE TO LOCK DOWN FROM COVID SO A VIDEO CALL WAS SCHEDULED BY A MAGSTIM ENGINEER TO ASSESS THE SITUATION. ON THE (B)(6) 2021 A MAGSTIM ENGINEER HAD A VIDEO CALL WITH (B)(4) (USER) AND (B)(4) FROM E SERVICES (DISTRIBUTOR). AND CARRIED OUT A FUNCTIONAL CHECK AND THE SYSTEM WAS WORKING OKAY APART FROM THE CURRENT CONFIRM WHICH WAS INTERMITTENTLY WORKING, THE GREEN LED DID NOT ALWAYS TURN ON WHEN THE STIM POD BLUE AND WHITE ELECTRODES WERE SHORT CIRCUITED. SWITCHED V4 MACHINE ON AND THEN OFF AGAIN AND THEN CURRENT CONFIRM WAS SEEN TO WORK. A REPLACEMENT STIMULATOR POD (4440-00) WILL BE ISSUED TO THE CUSTOMER AND THE SUSPECTED DEFECTIVE STIMULATOR POD WILL RETURNED UNDER RMA9923. AN INVESTIGATION WILL TAKE PLACE ON THE RETURNED ITEM. (B)(6) 2021 THE DEVICE HAS BEEN REQUESTED TO BE RETURNED AGAIN AND STILL AWAITING THE RETURN. ON THE (B)(6) 21 A CALL WAS HAD BETWEEN THE CUSTOMER AND A MAGSTIM REPRESENTATIVE REQUESTING THE RETURN OF THE DEVICE. ON THE (B)(6) 2021 A THIRD AND FINAL REQUEST WAS MADE FOR THE POSSIBLE FAULTY DEVICE BY EMAIL BEFORE SUBMITTING THIS REPORT. AS OF THE (B)(6) 2021 THERE HAS STILL BEEN NO RESPONSE FROM THE CUSTOMER IN TERMS OF RETURNING THE SUSPECTED FAULTY DEVICE. THERE HAVE BEEN MULTIPLE ATTEMPTS TO HAVE THE DEVICE RETURNED TO NO AVAIL. FROM DISCUSSIONS WITH THE CUSTOMER INITIALLY OVER SKYPE THE BEST ASSESSMENT THE MAGSTIM SERVICE DEPARTMENT HAVE IS A FAULTY V4 STIM CONNECTOR ASSY, THIS CANT BE CONFIRMED WITHOUT ACCESS TO THE SUSPECTED FAULTY DEVICE. AS SUCH, IN THE ABSENCE OF A RETURNED DEVICE NO FURTHER ROOT CAUSE ANALYSIS IS POSSIBLE. GIVEN THE ABOVE AND THE FACT THAT THE USER WAS PRESENTED WITH A NOTIFICATION BANNER AT THE TIME OF THE INITIAL FAULT THIS INCIDENT IS CONSIDERED NON-REPORTABLE. THE RISK ASSESSMENT CANNOT BE REVIEWED AS THE EXACT FAULT CANNOT BE ASSESSED DUE TO THE CUSTOMER NOT RETURNING THE SUSPECTED FAULTY DEVICE.
INITIALLY A VISIT OUT TO ACCESS THE DEVICE WAS SCHEDULED BY THE E SERVICES (DISTRIBUTER) IN CHILE BUT HAD TO BE CANCELLED DUE TO LOCK DOWN FROM COVID SO A VIDEO CALL WAS SCHEDULED BY A MAGSTIM ENGINEER TO ASSESS THE SITUATION. ON THE (B)(6) 2021 A MAGSTIM ENGINEER HAD A VIDEO CALL WITH ALEJANDRO CHERIT (USER) AND ADRIAN FROM E SERVICES (DISTRIBUTOR). AND CARRIED OUT A FUNCTIONAL CHECK AND THE SYSTEM WAS WORKING OKAY APART FROM THE CURRENT CONFIRM WHICH WAS INTERMITTENTLY WORKING, THE GREEN LED DID NOT ALWAYS TURN ON WHEN THE STIM POD BLUE AND WHITE ELECTRODES WERE SHORT CIRCUITED. SWITCHED V4 MACHINE ON AND THEN OFF AGAIN AND THEN CURRENT CONFIRM WAS SEEN TO WORK. A REPLACEMENT STIMULATOR POD (4440-00) WILL BE ISSUED TO THE CUSTOMER AND THE SUSPECTED DEFECTIVE STIMULATOR POD WILL RETURNED UNDER RMA9923. AN INVESTIGATION WILL TAKE PLACE ON THE RETURNED ITEM. ON THE 10/09/2021 THE DEVICE HAS BEEN REQUESTED TO BE RETURNED AGAIN AND STILL AWAITING THE RETURN. ON THE 5/10/21 A CALL WAS HAD BETWEEN THE CUSTOMER AND A MAGSTIM REPRESENTATIVE REQUESTING THE RETURN OF THE DEVICE. ON THE 02/11/2021 A THIRD AND FINAL REQUEST WAS MADE FOR THE POSSIBLE FAULTY DEVICE BY EMAIL BEFORE SUBMITTING THIS REPORT.
ON THE (B)(6) 2021 IT WAS REPORTED THAT DURING A SURGERY, ONCE THE ELECTRODES WERE PLACED ON THE PATIENT, THE EQUIPMENT WAS TURNED ON AND THE IMPEDANCES OF THE ACTIVE CHANNELS WERE MEASURED, WHICH CONFIRMED THEIR GOOD POSITIONING (GREEN COLOR IN THE CHANNELS).ONCE THE IMPEDANCES WERE CHECKED, THE USER STARTED THE STUDY AND DID A TEST TO VERIFY THAT THE CIRCUIT WAS CONNECTED CALLED "TAP TEST" WHICH CONSISTS OF HITTING THE SKIN ON THE ELECTRODES TO SEE IF AN ARTIFACT IS GENERATED, WHICH CONFIRMS THAT THE CIRCUIT IS WELL CONNECTED. EVERYTHING WAS GOING WELL, AS USUAL, UNTIL THE DOCTOR DECIDED TO USE THE STIMULATION PROBE, SINCE THE CURRENT CONFIRM BUTTON WAS LIT GREEN BUT NO RESPONSE WAS PRODUCED (VALUES FROM 0.5 MA TO 3.0 MA WERE TRIED WITH A PULSE FROM 200US TO 30 HZ). DURING STIMULATION AN ERROR APPEARS ON THE UPPER EDGE OF THE YELLOW SCREEN "STIMULATOR HEAD DISCONNECTED, CONTACT THE MANUFACTURER", IMMEDIATELY AFTERWARDS THEY TURNED OFF THE MACHINE AND RECONNECTED THE ENTIRE CIRCUIT. WHEN THEY TURNED ON THE MACHINE AGAIN, THE ERROR MESSAGE NO LONGER APPEARED. IT PROCEEDED TO STIMULATE SEVERAL TIMES, ALL WITH THE GREEN LIGHT ON CURRENT CONFIRM, BUT THERE WAS NO RESPONSE. AT THIS MOMENT THE DOCTOR STOPPED LEANING ON THE MONITOR, UNTIL JUST THE END OF THE SURGERY, WHERE AN EMG SIGNAL APPEARS AS A RESULT OF MECHANICAL STIMULATION OF THE NERVE. RIGHT AFTER THIS MECHANICAL STIMULATION, ELECTRICAL STIMULATION WAS TESTED AT 0.8 MA WITH A POSITIVE EMG RESPONSE IN THE SAME PLACE THAT PREVIOUSLY GAVE NO RESPONSE TO 3 MA, BUT THIS RESPONSE WAS DIFFERENT FROM THE USUAL ONES SINCE THE EMG SIGNALS WERE NOT UPDATED AS USUAL . IT IS WORTH NOTING THAT THE DOCTOR IS EXPERIENCED IN BOTH SURGERY AND THE USE OF THE V4 EQUIPMENT. REASON WHY IT IS RULED OUT THAT THE PATIENT HAD BEEN WITH ANESTHETIC NEUROMUSCULAR BLOCK, AS WELL AS CURRENT DISPERSION DUE TO FLUID OR OTHER FAILURES INHERENT TO SURGERY.
ON THE (B)(6) 2021 IT WAS REPORTED THAT DURING A SURGERY, ONCE THE ELECTRODES WERE PLACED ON THE PATIENT, THE EQUIPMENT WAS TURNED ON AND THE IMPEDANCES OF THE ACTIVE CHANNELS WERE MEASURED, WHICH CONFIRMED THEIR GOOD POSITIONING (GREEN COLOR IN THE CHANNELS).ONCE THE IMPEDANCES WERE CHECKED, THE USER STARTED THE STUDY AND DID A TEST TO VERIFY THAT THE CIRCUIT WAS CONNECTED CALLED "TAP TEST" WHICH CONSISTS OF HITTING THE SKIN ON THE ELECTRODES TO SEE IF AN ARTIFACT IS GENERATED, WHICH CONFIRMS THAT THE CIRCUIT IS WELL CONNECTED. EVERYTHING WAS GOING WELL, AS USUAL, UNTIL THE DOCTOR DECIDED TO USE THE STIMULATION PROBE, SINCE THE CURRENT CONFIRM BUTTON WAS LIT GREEN BUT NO RESPONSE WAS PRODUCED (VALUES FROM 0.5 MA TO 3.0 MA WERE TRIED WITH A PULSE FROM 200US TO 30 HZ). DURING STIMULATION AN ERROR APPEARS ON THE UPPER EDGE OF THE YELLOW SCREEN "STIMULATOR HEAD DISCONNECTED, CONTACT THE MANUFACTURER", IMMEDIATELY AFTERWARDS THEY TURNED OFF THE MACHINE AND RECONNECTED THE ENTIRE CIRCUIT. WHEN THEY TURNED ON THE MACHINE AGAIN, THE ERROR MESSAGE NO LONGER APPEARED. IT PROCEEDED TO STIMULATE SEVERAL TIMES, ALL WITH THE GREEN LIGHT ON CURRENT CONFIRM, BUT THERE WAS NO RESPONSE. AT THIS MOMENT THE DOCTOR STOPPED LEANING ON THE MONITOR, UNTIL JUST THE END OF THE SURGERY, WHERE AN EMG SIGNAL APPEARS AS A RESULT OF MECHANICAL STIMULATION OF THE NERVE. RIGHT AFTER THIS MECHANICAL STIMULATION, ELECTRICAL STIMULATION WAS TESTED AT 0.8 MA WITH A POSITIVE EMG RESPONSE IN THE SAME PLACE THAT PREVIOUSLY GAVE NO RESPONSE TO 3 MA, BUT THIS RESPONSE WAS DIFFERENT FROM THE USUAL ONES SINCE THE EMG SIGNALS WERE NOT UPDATED AS USUAL . IT IS WORTH NOTING THAT THE DOCTOR IS EXPERIENCED IN BOTH SURGERY AND THE USE OF THE V4 EQUIPMENT. REASON WHY IT IS RULED OUT THAT THE PATIENT HAD BEEN WITH ANESTHETIC NEUROMUSCULAR BLOCK, AS WELL AS CURRENT DISPERSION DUE TO FLUID OR OTHER FAILURES INHERENT TO SURGERY.
INITIALLY A VISIT OUT TO ACCESS THE DEVICE WAS SCHEDULED BY THE (B)(4) BUT HAD TO BE CANCELLED DUE TO LOCK DOWN FROM COVID SO A VIDEO CALL WAS SCHEDULED BY A MAGSTIM ENGINEER TO ASSESS THE SITUATION. ON THE 29/06/2021, A MAGSTIM ENGINEER HAD A VIDEO CALL WITH (B)(6) (USER) AND (B)(4) (DISTRIBUTOR), AND CARRIED OUT A FUNCTIONAL CHECK AND THE SYSTEM WAS WORKING OKAY APART FROM THE CURRENT CONFIRM WHICH WAS INTERMITTENTLY WORKING, THE GREEN LED DID NOT ALWAYS TURN ON WHEN THE STIM POD BLUE AND WHITE ELECTRODES WERE SHORT CIRCUITED. SWITCHED V4 MACHINE ON AND THEN OFF AGAIN, AND THEN CURRENT CONFIRM WAS SEEN TO WORK. POSSIBLE INTERMITTENT CONNECTION OF STIM POD. A REPLACEMENT STIMULATOR POD (4440-00) WILL BE ISSUED TO THE CUSTOMER AND THE SUSPECTED DEFECTIVE STIMULATOR POD WILL RETURNED UNDER (B)(4). AN INVESTIGATION WILL TAKE PLACE ON THE RETURNED ITEM.
ON (B)(6) 2021, IT WAS REPORTED THAT DURING A SURGERY, ONCE THE ELECTRODES WERE PLACED ON THE PATIENT, THE EQUIPMENT WAS TURNED ON AND THE IMPEDANCES OF THE ACTIVE CHANNELS WERE MEASURED, WHICH CONFIRMED THEIR GOOD POSITIONING (GREEN COLOR IN THE CHANNELS). ONCE THE IMPEDANCES WERE CHECKED, THE USER STARTED THE STUDY AND DID A TEST TO VERIFY THAT THE CIRCUIT WAS CONNECTED CALLED "TAP TEST" WHICH CONSISTS OF HITTING THE SKIN ON THE ELECTRODES TO SEE IF AN ARTIFACT IS GENERATED, WHICH CONFIRMS THAT THE CIRCUIT IS WELL CONNECTED. EVERYTHING WAS GOING WELL, AS USUAL, UNTIL THE DOCTOR DECIDED TO USE THE STIMULATION PROBE, SINCE THE CURRENT CONFIRM BUTTON WAS LIT GREEN BUT NO RESPONSE WAS PRODUCED (VALUES FROM 0.5 MA TO 3.0 MA WERE TRIED WITH A PULSE FROM 200US TO 30 HZ). DURING STIMULATION AN ERROR APPEARS ON THE UPPER EDGE OF THE YELLOW SCREEN "STIMULATOR HEAD DISCONNECTED, CONTACT THE MANUFACTURER", IMMEDIATELY AFTERWARDS THEY TURNED OFF THE MACHINE AND RECONNECTED THE ENTIRE CIRCUIT. WHEN THEY TURNED ON THE MACHINE AGAIN, THE ERROR MESSAGE NO LONGER APPEARED. IT PROCEEDED TO STIMULATE SEVERAL TIMES, ALL WITH THE GREEN LIGHT ON CURRENT CONFIRM, BUT THERE WAS NO RESPONSE. AT THIS MOMENT THE DOCTOR STOPPED LEANING ON THE MONITOR, UNTIL JUST THE END OF THE SURGERY, WHERE AN EMG SIGNAL APPEARS AS A RESULT OF MECHANICAL STIMULATION OF THE NERVE. RIGHT AFTER THIS MECHANICAL STIMULATION, ELECTRICAL STIMULATION WAS TESTED AT 0.8 MA WITH A POSITIVE EMG RESPONSE IN THE SAME PLACE THAT PREVIOUSLY GAVE NO RESPONSE TO 3 MA, BUT THIS RESPONSE WAS DIFFERENT FROM THE USUAL ONES SINCE THE EMG SIGNALS WERE NOT UPDATED AS USUAL . IT IS WORTH NOTING THAT THE DOCTOR IS EXPERIENCED IN BOTH SURGERY AND THE USE OF THE V4 EQUIPMENT. REASON WHY IT IS RULED OUT THAT THE PATIENT HAD BEEN WITH ANESTHETIC NEUROMUSCULAR BLOCK, AS WELL AS CURRENT DISPERSION DUE TO FLUID OR OTHER FAILURES INHERENT TO SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1042050 | NEUROSIGN | NEUROSIGN V4 | ETN | THE MAGSTIM COMPANY LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |