NIM Vital™ NIM4CM01 (UDI 00763000002978)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00763000002978), received between Oct 27, 2022 and Sep 29, 2026 — classified as 2 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (34 reports).

3 FDA recall records name this device's identifier, 3 still open.

1 other recall cover devices cleared under the same FDA submission (K200759); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 10, 2025Class IIOpen, Classified

   Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

   Z-1623-2025 · Root cause: Software change control · Recall details · FDA record ↗

2. Jun 24, 2024Class IOpen, Classified

   Potential for false negative response on the NIM Vital Nerve Monitoring System

   Z-2409-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 3, 2022Class IIOpen, Classified

   Software anomaly was identified.

   Z-1223-2022 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026False Negative Result

  It was reported that intra-op, the NIM Vital was giving an audible alarm approximately every minute with no corresponding alarm message displayed on screen. All connections were confirmed correct. The stimulation delivery tone was absent, although visual stimulation feedback was displayed under the stimulation current and muscle twitch was observed. No passive EMG activity was detected with Event Capture turned off, and no nerve response was observed when stimulating the RLN. Changing patient interfaces, using hard wire connections and rebooting the unit (unplugged for 30 seconds) did not resolve the issue. Adjusting the volume reportedly restored operation however, due to the abnormal behavior, Medtronic recommended that the unit be assessed by a service engineer. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928090 ↗
• MalfunctionAug 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170058 ↗
• MalfunctionJun 4, 2026Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE CONSOLE HAD THE ERROR 'SELF TEST FAILED' AFTER BOOTING UP THEN FORCES A SHUTDOWN. PATIENT INTERFACE HAD SOFTWARE ISSUE. CABLE WAS REPLACED BUT THE BUTTON 'UPDATE NOW' REMAIN GRAYED OUT. PATIENT INTERFACE ARE ALSO NOT RECOGNIZED AS DEVICE IN SETTING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25387275 ↗
• MalfunctionDec 11, 2025Application Program Freezes or Fails to Launch; Incomplete or Inadequate Connection; Application Program Freezes or Fails to Launch; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE SCREEN FREEZES IN THE NIM CONSOLE AND THERE WAS A CONNECTION PROBLEM WITH THE PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23775104 ↗
• MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE ISSUE OCCURRED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WORKED AS INTENDED AFTER SEVERAL SHUT DOWN AND RESTARTS.

  Patient problems: Insufficient Information

  MAUDE report 23287654 ↗
• MalfunctionJul 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Misassembled During Manufacturing /Shipping; Incomplete or Inadequate Connection; Incorrect, Inadequate or Imprecise Result or Readings; Device Misassembled During Manufacturing /Shipping; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT CONSOLE NEEDS A COMPLETE CHECK- UP. THE BATTERY DOES NOT WORK, OR IS MISSING, ONE OF THE USB PORTS IS DAMAGED. BLUETOOTH CONNECTION IS NOT STABLE DESPITE IT BEING ON LATEST SOFTWARE VERSION. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392177 ↗
• MalfunctionJun 23, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT PRE-OP, THE NIM VITAL WAS UNABLE OR INTERMITTENTLY NOT CONNECTING TO THE INTERFACE USING WIRELESS MODE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305500 ↗
• MalfunctionMay 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE DEVICE STARTED NORMALLY, THE TEST PASSED NORMALLY. THE PATIENT INTERFACE WAS CONNECTED TO WI-FI. THE OPERATION BEGAN. THE DEVICE STARTED MAKING A SHRILL NOISE, AND A MESSAGE APPEARED ON THE SCREEN "THE QUALITY OF THE PATIENT INTERFACE WIRELESS CONNECTION IS POOR OR ANOTHER DEVICE IS INTERFERING WITH ITS CONNECTION. CONNECT THE PATIENT INTERFACE CABLE". USER CHECKED THE SIGNAL (IT WAS GOOD WITH 3 RODS) AND CLOSED THE ALERT MESSAGE BY CONNECTING THE INTERNET CABLE. THE OPERATION CONTINUED, AND THE SURGEON WAS ABLE TO FIND THE NERVE (POSITIVE RESPONSE TO STIMULATION). THE DEVICE BEEPED AGAIN SHRILLY, WITH A MESSAGE ON THE SCREEN. THE MESSAGE INDICATES THAT THE CONSOLE BATTERY IS UNAVAILABLE, MAINTENANCE AND REPAIR SHOULD BE CONTACTED. YET ON SCREEN AND ON PATIENT INTERFACE, THE LOADING BARS WERE AT MAXIMUM. WHEN THE OPERATION WAS COMPLETE, USER TURNED OFF THE DEVICE AND REBOOTED IT. USER RAN A TEST CASE AND THE LOUD ALARM WITH THE MESSAGE REAPPEARED WHEN CONNECTED WIRELESSLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991277 ↗
• MalfunctionMay 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE AFTER UPDATING THE SOFTWARE TO 1.7.5 AFTER STIMULATING THE N. VAGUS WITH THE HAND PROBE THE APS ELECTRODE IS PLACED. WHILE THE PROCEDURE IS TAKING ON THE APS PROBE STOPS TO STIMULATE FROM TIME TO TIME FOR 4-5 SECONDS, IT IS LIKE THE SIGNAL IS SHUT DOWN DUE TO ARTEFACTS BUT THERE IS NOTHING COULD CAUSE ARTEFACTS IN THIS SPECIAL MOMENTS. THE APS VALUE WAS ABOUT 600UV AND 280UM AND THEN PAUSED WITHOUT A REASON FOR 4-5 SECONDS, THE SIGNAL DID NOT FALL IN IT INTENSITY. THERE WAS NO DELIVERY TONE HEARD WHEN STIMULATING AND NO WAVEFORM DISPLAYED. THE PROCEDURE WAS COMPLETED BY REPORTED PRODUCTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958531 ↗
• InjuryApr 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP DURING THYROIDECTOMY PROCEDURE, THE NIM VITAL DELIVERED A VERY HIGH CURRENT STIMULUS WHICH CAUSED VOCAL CORD PARALYSIS TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATED THAT STANDARD PROBE WAS USED FOR STIMULATION DELIVERY. THE STIMULATION WAS ALL THE TIME BETWEEN 1 AND 2MA. RECURRENT NERVE WAS BEING STIMULATED WITH CONCERN FOR HIGH CURRENT DELIVERY. THE PATIENT EXPERIENCED VOCAL FOLD PARALYSIS INTRA-OPERATIVELY. THE NIM WAS WORKING AS EXPECTED. THE ELECTROSURGERY AND VESSEL SEALER INSTRUMENTS WERE USED TOO. THE SYSTEM DELIVERED HIGHER CURRENT BY ERROR.

  Patient problems: Paralysis

  MAUDE report 21923931 ↗
• InjuryApr 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP DURING THYROIDECTOMY PROCEDURE, THE NIM VITAL DELIVERED A VERY HIGH CURRENT STIMULUS WHICH CAUSED VOCAL CORD PARALYSIS TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATED THAT STANDARD PROBE WAS USED FOR STIMULATION DELIVERY. THE STIMULATION WAS ALL THE TIME BETWEEN 1 AND 2MA. RECURRENT NERVE WAS BEING STIMULATED WITH CONCERN FOR HIGH CURRENT DELIVERY. THE PATIENT EXPERIENCED VOCAL FOLD PARALYSIS INTRA-OPERATIVELY. THE PATIENT NEEDED A TRACHEOSTOMY POST-OPERATIVELY TO IMPROVE THE PATIENTS CONDITION. THE NIM WAS WORKING AS EXPECTED. THE ELECTROSURGERY AND VESSEL SEALER INSTRUMENTS WERE USED TOO. THE SYSTEM DELIVERED HIGHER CURRENT BY ERROR.

  Patient problems: Paralysis

  MAUDE report 21923930 ↗
• MalfunctionApr 15, 2025Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TESTING, THE DEVICE SEEMS TO HAVE A SOFTWARE ISSUE. TAKING ABOUT TEN MINUTES TO BOOT UP AND A LONG TIME TO POWER OFF. IT WAS INTERMITTENTLY WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21838045 ↗
• MalfunctionMar 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE STARTING THE SYSTEM, THE NIM CONSOLE DIDN¿T PASSED THE SELF TEST SEVERAL TIME, THE INSIDE OF THE USB SLOT WAS BROKEN AND CANNOT PUT ANY USB STICK IN THERE AND THE PATIENT INTERFACE WAS NOT RECOGNIZED AFTER CONNECTING, THE ISSUE OCCURRED ON WIRED MODE, THE PATIENT INTERFACE DID NOT PASS THE TEST 3 TIMES AND SELF TEST ERROR HAS APPEARED. THE ISSUE DID NOT OCCUR WHILE A PROCEDURE TOOK PLACE, THE ERROR OCCURRED WHILE UPDATING THE PATIENT INTERFACE TO THE LATEST SOFTWARE. THE PATIENT INTERFACE WAS WORKING FINE WHEN IT WAS TESTED WITH ANOTHER CONSOLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675524 ↗
• MalfunctionFeb 25, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Battery Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Battery Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICES WERE INITIALLY ON WIRELESS MODE WHEN THE UNIT INDICATED THAT THE BATTERY OF THE PATIENT INTERFACE WAS RUNNING OUT. THIS LED TO THE DISCOVERY THAT THE CABLE WAS NOT FUNCTIONING AND THE WIRE CONNECTION TO THE PATIENT INTERFACE WAS DISCONNECTING. INITIALLY, THE USER THOUGHT IT WAS THE WIRE CORD, SO THEY REPLACED THE WIRE. HOWEVER, A FEW MINUTES LATER, IT STILL DISCONNECTED. THE USER THEN CHANGED THE PATIENT INTERFACE, BUT IT STILL HAD THE SAME RESULT. SO, CHANGED THE CONSOLE AND IT STARTED WORKING. THE USER TESTED THE UNIT BEFORE THE CASE STARTED, AND IT WAS CONNECTING AND READING WELL. HOWEVER, IN THE MIDDLE OF THE CASE, THE CORD CONNECTION DISCONNECTED AGAIN. THE PATIENT INTERFACE TRIED TO CONNECT IN WIRELESS MODE, BUT IT DID NOT WORK. STATIC NOISE AND A HUGE SPIKE WERE OBSERVED WHEN AN ESU WAS ACTIVATED. FALSE POSITIVE READINGS WERE OBSERVED THIS MEAN SPIKES ON THE READINGS JUMPS WHILE THE HANDPIECE WAS NO WHERE NEAR THE SITE. THE PATIENT INTERFACE CABLES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NIM CONSOLE AND PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456798 ↗
• MalfunctionFeb 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Battery Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Battery Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICES WERE INITIALLY ON WIRELESS MODE WHEN THE UNIT INDICATED THAT THE BATTERY OF THE PATIENT INTERFACE WAS RUNNING OUT. THIS LED TO THE DISCOVERY THAT THE CABLE WAS NOT FUNCTIONING AND THE WIRE CONNECTION TO THE PATIENT INTERFACE WAS DISCONNECTING. INITIALLY, THE USER THOUGHT IT WAS THE WIRE CORD, SO THEY REPLACED THE WIRE. HOWEVER, A FEW MINUTES LATER, IT STILL DISCONNECTED. THE USER THEN CHANGED THE PATIENT INTERFACE, BUT IT STILL HAD THE SAME RESULT. SO, CHANGED THE CONSOLE AND IT STARTED WORKING. THE USER TESTED THE UNIT BEFORE THE CASE STARTED, AND IT WAS CONNECTING AND READING WELL. HOWEVER, IN THE MIDDLE OF THE CASE, THE CORD CONNECTION DISCONNECTED AGAIN. THE PATIENT INTERFACE TRIED TO CONNECT IN WIRELESS MODE, BUT IT DID NOT WORK. STATIC NOISE AND A HUGE SPIKE WERE OBSERVED WHEN AN ESU WAS ACTIVATED. THE PATIENT INTERFACE CABLES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NIM CONSOLE AND PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456446 ↗
• MalfunctionFeb 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Battery Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Battery Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICES WERE INITIALLY ON WIRELESS MODE WHEN THE UNIT INDICATED THAT THE BATTERY OF THE PATIENT INTERFACE WAS RUNNING OUT. THIS LED TO THE DISCOVERY THAT THE CABLE WAS NOT FUNCTIONING AND THE WIRE CONNECTION TO THE PATIENT INTERFACE WAS DISCONNECTING. INITIALLY, THE USER THOUGHT IT WAS THE WIRE CORD, SO THEY REPLACED THE WIRE. HOWEVER, A FEW MINUTES LATER, IT STILL DISCONNECTED. THE USER THEN CHANGED THE PATIENT INTERFACE, BUT IT STILL HAD THE SAME RESULT. SO, CHANGED THE CONSOLE AND IT STARTED WORKING. THE USER TESTED THE UNIT BEFORE THE CASE STARTED, AND IT WAS CONNECTING AND READING WELL. HOWEVER, IN THE MIDDLE OF THE CASE, THE CORD CONNECTION DISCONNECTED AGAIN. THE PATIENT INTERFACE TRIED TO CONNECT IN WIRELESS MODE, BUT IT DID NOT WORK. STATIC NOISE AND A HUGE SPIKE WERE OBSERVED WHEN AN ESU WAS ACTIVATED. THE PATIENT INTERFACE CABLES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NIM CONSOLE AND PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456171 ↗
• MalfunctionFeb 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Battery Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Battery Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICES WERE INITIALLY ON WIRELESS MODE WHEN THE UNIT INDICATED THAT THE BATTERY OF THE PATIENT INTERFACE WAS RUNNING OUT. THIS LED TO THE DISCOVERY THAT THE CABLE WAS NOT FUNCTIONING AND THE WIRE CONNECTION TO THE PATIENT INTERFACE WAS DISCONNECTING. INITIALLY, THE USER THOUGHT IT WAS THE WIRE CORD, SO THEY REPLACED THE WIRE. HOWEVER, A FEW MINUTES LATER, IT STILL DISCONNECTED. THE USER THEN CHANGED THE PATIENT INTERFACE, BUT IT STILL HAD THE SAME RESULT. SO, CHANGED THE CONSOLE AND IT STARTED WORKING. THE USER TESTED THE UNIT BEFORE THE CASE STARTED, AND IT WAS CONNECTING AND READING WELL. HOWEVER, IN THE MIDDLE OF THE CASE, THE CORD CONNECTION DISCONNECTED AGAIN. THE PATIENT INTERFACE TRIED TO CONNECT IN WIRELESS MODE, BUT IT DID NOT WORK. STATIC NOISE AND A HUGE SPIKE WERE OBSERVED WHEN AN ESU WAS ACTIVATED. THE PATIENT INTERFACE CABLES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NIM CONSOLE AND PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456099 ↗
• MalfunctionDec 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PROBLEM WITH THE ANTI-INTERFERENCE CONNECTORS AND ON WHICH THE BATTERY IS MISSING. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025301 ↗
• MalfunctionDec 9, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT INTRA-OP, NIM VITAL HAD INTERFERENCE FROM BOVEY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878656 ↗
• MalfunctionNov 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WIRED CONNECTION TO THE PATIENT INTERFACE IS NOT WORKING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20721224 ↗
• MalfunctionNov 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE ELECTRODE AND PROBE PLACEMENT PROCEDURE, THE SYSTEM RANDOMLY DISPLAYED AN ERROR MESSAGE STATING "OUT OF MEASUREMENT RANGE." A VERY LOUD SOUND WAS EMITTED WHENEVER THE SYSTEM TRIGGERED THIS ALARM. AFTER ABOUT FIVE SECONDS OF THE ERROR MESSAGE AND LOUD SOUNDS, THE ERROR WOULD GO AWAY, ALLOWING THEM TO RESUME SURGERY. HOWEVER, THE ISSUE OCCURRED RANDOMLY AND FREQUENTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609132 ↗
• MalfunctionOct 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP, THE NIM VITAL CONSOLE HAD EMG MONITORING DISPLAYED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546996 ↗
• MalfunctionOct 19, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT "THE NIM VITAL WON'T TURN ON" NIM VITAL TEXT WOULD APPEAR WHEN TURNING ON SYSTEM AND THEN SCREEN WOULD GO BLANK. TROUBLESHOOTING ADVICE WAS TO LEAVE THE NIM VITAL PLUGGED IN OVERNIGHT AND REBOOT. LEFT SYSTEM PLUGGED IN OVERNIGHT AND REBOOTED WITH SAME OCCURRENCE. NIM VITAL TEXT WOULD APPEAR FOR A SECOND AND TURN BLANK AFTERWARDS. CHECKED SYSTEM WAS PLUGGED IN. CUSTOMER CONFIRMED THE PATIENT INTERFACES APPEARED TO BE CHARGING. BACKUP NIM3 SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488943 ↗
• MalfunctionOct 14, 2024Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE NIM VITAL WAS NOT BOOTING UP, BATTERY BACK UP WILL NOT WORK AND MAIN USB PORT WORKS INCONSISTENTLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436708 ↗
• MalfunctionOct 11, 2024Inappropriate Audible Prompt/Feedback; Problem with Software Installation; Inappropriate Audible Prompt/Feedback; Problem with Software Installation

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE FIRST NIM UNIT HAD "UNABLE TO UPDATE" ERROR MESSAGE WITH THE INTERFACE, SECOND NIM UNIT HAD CONTINUOUS STATIC INTERFERENCE. THIRD NIM WORKED FINE. PATIENT INTERFACE BOX WORKED FINE AFTER SOFTWARE UPGRADE. THE PROCEDURE WAS DELAYED BY 60 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200759. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2022 · May 3, 2022 · Open, Classified
  NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2