N/A 945DAQ916Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169071933), received between Jan 11, 2018 and Dec 28, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (8 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-OP, THE PREAMPLIFIER NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904007 ↗
• MalfunctionNov 18, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THAT DEVICE GROUNDING WAS INTERMITTENT. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23590413 ↗
• MalfunctionNov 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE NIM ECLIPSE AMPLIFIED HAD PORT 5 AND 10 OUT. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23569370 ↗
• MalfunctionSep 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DAQ BOX FAILED AFTER GETTING FLUID ON IT, A SPARE DEVICE WAS USED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23028799 ↗
• MalfunctionNov 6, 2024Use of Device Problem; Connection Problem; Use of Device Problem; Connection Problem

  ADDITIONAL INFORMATION RECEVIED THAT THE FEW PORTS WERE NOT WORKING. PORTS SHOWING RED LIGHT, DISCONNECTED. THERE WAS A CONNECTOR ISSUE. RECONNECTED ALL CABLE CONNECTIONS AND CHECKED IT. REPLACEMENT DEVICE WAS USED FOR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20617644 ↗
• MalfunctionOct 1, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED THAT CHANNEL PORT 11,19,28 AND 32 FOUND OPEN WHILE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342998 ↗
• MalfunctionNov 21, 2023Sensing Intermittently; Sensing Intermittently

  IT WAS REPORTED THAT DEVICE PORT 13 INTERMITTENT DURING TESTING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184655 ↗
• MalfunctionNov 9, 2023Crack; Crack

  IT WAS REPORTED THAT THE DEVICE CRACK IN TOP OF DAQ BOX PRESENT SINCE CLINICIAN INITIALLY RECEIVED HOWEVER NEVER IMPACTED FUNCTIONALITY. IN CASE ON 10/10 (125510) ARTIFACT PRESENT NOT SEEN BEFORE. CLINICIAN ATTEMPTED TO MOVE DAQ BOX FROM OR TABLE TO ANOTHER LOCATION (ANESTHESIA POLE). DAQ NOT DROPPED, PULLED/TUGGED, TWISTED, ONLY MOVEMENT WAS CAREFULLY TAKING OFF ORIGINAL SPOT TO NEW. A PIECE OF TOP, AND THEN ENTIRE BACK, OF DAQ FELL OFF WHEN LIFTED FROM ANESTHESIA POLE. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP ADDITIONAL INFORMATION RECEIVED ISSUE WAS NOT DISCOVERED PRIOR TO USE, BUT FORTUNATELY EARLY IN THE CASE AND THE DAQ WAS SWITCHED OUT WITH NO IMPACT. THERE WAS NO VISUAL AND/OR AUDIBLE INDICATORS ALERTED THE USER. SEEMED TO HAVE BE A PHYSICAL ISSUE. ARTIFACT WAS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100228 ↗
• MalfunctionMay 28, 2020Use of Device Problem; Use of Device Problem

  THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS NOT FUNCTIONING CORRECTLY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10095440 ↗
• MalfunctionDec 2, 2019Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT A NERVE MONITORING DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9394625 ↗
• MalfunctionOct 12, 2018Use of Device Problem; Impedance Problem; Use of Device Problem; Impedance Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICE FAILED THE IMPEDANCE TEST AND WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7962826 ↗
• MalfunctionAug 29, 2018Loose or Intermittent Connection; Use of Device Problem; Fitting Problem; Loose or Intermittent Connection; Use of Device Problem; Fitting Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING, WORKED INTERMITTENTLY AND PORT 3 WAS LOOSE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7826456 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CNIM (CERTIFIED NEUROPHYSIOLOGICAL INTRAOPERATIVE MONITOR) THAT ABOUT 20 MINUTES INTO AND ANTERIOR LUMBAR INTERBODY FUSION (ALIF) THE SURGEON USED THE BOVIE CAUTERY, WHICH CREATED THE EXPECTED ARTIFACT. A MINUTE LATER THE ARTIFACT WAS STILL PRESENT, BUT WHEN INQUIRING AS TO WHY THE BOVIE WAS STILL IN USE, HE WAS TOLD IT WAS NOT. ¿THERE WAS A SURGE THAT TOOK OUT ALL THE EQUIPMENT.¿ HE CHECKED THE BOVIE GROUNDING PAD AND IT FELT FINE; IT WAS NOT WET OR LOOSE. THE SURGE CAUSED THE DAQ PRE-AMP TO ¿BLOW¿. THEY CHECKED ALL LEADS, CONNECTIONS, UNPLUGGED AND RE-PLUGGED EVERYTHING, AND EVERYTHING APPEARED TO BE WORKING, EXCEPT THE DAQ. IT WAS CONFIRMED THAT THE EQUIPMENT WAS PLUGGED INTO A SURGE PROTECTOR; ALSO, NONE OF THE NIM COMPONENTS, CABLES OR CORDS WERE TOUCHING ANY OF THE ELECTRICAL EQUIPMENT OR THE BOVIE EQUIPMENT. THE CAUSE OF THIS ISSUE IS BELIEVED TO BE THAT THE BOVIE CURRENT, 240 VOLTS, WENT TO THE BOVIE GROUNDING PAD, HOWEVER IT WASN¿T WORKING CORRECTLY. AT THAT POINT THE CURRENT USED THE ELECTRODES (RECORDING NEEDLES; NON-MEDTRONIC PRODUCT) AS THE GROUND; THE CURRENT USED THE ELECTRODE NEEDLES INSTEAD OF THE BOVIE PAD TO COMPLETE THE CIRCUIT. ANESTHESIA

  Patient problems: Lead(s), Burn(s) From; Radiation Exposure, Unintended

  MAUDE report 7184901 ↗