NA DAQ916 (UDI 00613994910950)Recalls & reported problems
Medtronic Xomed, Inc. · PREAMPLIFIER DAQ916 DIGITAL · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic Xomed digital preamplifier, the DAQ916 unit used in the NIM Eclipse nerve-monitoring system during surgery. The 27 reports mostly describe the unit not working or picking up no signal when checked before an operation, along with abnormal waveforms and connection or sensing problems. There were no deaths and no injuries, and reports note no patient impact. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00613994910950), received between Jan 20, 2017 and Dec 2, 2025 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem17
- Incorrect, Inadequate or Imprecise Result or Readings4
- Unable to Obtain Readings4
- Device Operates Differently Than Expected2
- Circuit Failure1
- Connection Problem1
- Device Sensing Problem1
- Device Stops Intermittently1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT PRE-OP, THE PREAMPLIFIER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23689925 ↗MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE, THE NIM ECLIPSE WAS NOT WORKING PROPERLY, THE PRE-AMPLIFIER IN THE NIM ECLIPSE SYSTEM WAS NOT DETECTING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277057 ↗MalfunctionSep 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE, THE NIM ECLIPSE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT, THE PRE-AMPLIFIER IN THE NIM ECLIPSE SYSTEM WAS NOT DETECTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026766 ↗MalfunctionAug 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Intermittent Loss of Power; Incorrect, Inadequate or Imprecise Result or Readings; Intermittent Loss of Power
IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22768318 ↗MalfunctionApr 1, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-OP, THE AMPLIFIER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21736010 ↗MalfunctionFeb 6, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT BEFORE OPERATION, THE PRE-AMPLIFIER JACK HAD NO SIGNAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322152 ↗MalfunctionNov 11, 2024Display or Visual Feedback Problem; Unable to Obtain Readings; Use of Device Problem; Display or Visual Feedback Problem; Unable to Obtain Readings; Use of Device Problem
IT WAS REPORTED THAT INTRA-OP, A PARASITE ON ONE OF THE TRACKS WITHOUT CONNECTING IT, MISSING CE CODE AND IT WAS IMPOSSIBLE TO HAVE NERVES POTENTIALS. THE SCREEN WAS NOT WORKING. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20657991 ↗MalfunctionJul 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING PRE-OP, THE PREAMPLIFIER HAD NO STIM RESPONSE. STIM RETURN WAS CONSISTENT WITH THE SET VALUE. THE WAVEFORM OF THE AMPLIFIER WAS ABNORMAL AFTER TURNING IT ON. RESTARTING IT SEVERAL TIMES DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19789972 ↗MalfunctionJan 16, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE DEVICE EXIT 9 AND 17 WERE WORKING INTERMITTENT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE EVENT OCCURRED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18515686 ↗MalfunctionJan 2, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS MULTIPLE MALFUNCTION WITH THE DEVICE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16084246 ↗MalfunctionAug 5, 2021Use of Device Problem; Use of Device Problem
A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PREAMPLIFIER WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12281675 ↗MalfunctionApr 8, 2021Use of Device Problem; Use of Device Problem
ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO DATA REGARDING STIMULATION AND WAS DISCOVERED PRIOR USING ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11633714 ↗MalfunctionDec 28, 2020Use of Device Problem; Use of Device Problem
A HEALTH CARE PROVIDER (HCP) REPORTED THAT A DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11076192 ↗MalfunctionDec 15, 2020Use of Device Problem; Use of Device Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PREAMP WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11011107 ↗MalfunctionDec 15, 2020Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem
A HEALTH CARE PROVIDER REPORTED THAT THE PREAMPLIFIER WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11010965 ↗MalfunctionSep 2, 2020Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem
ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THERE WAS NO STIMULATION DURING THE PROCEDURE. THEY DID NOT HEAR/SEE ANYTHING THAT MADE THEM AWARE THAT THERE WAS SOMETHING WRONG WITH THE DEVICE. THEY TRIED SWITCHING THE DEVICE OFF AND ON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10481240 ↗MalfunctionJul 23, 2020Use of Device Problem; Connection Problem; Material Deformation; Use of Device Problem; Connection Problem; Material Deformation
A HEALTH CARE PROVIDER REPORTED THAT THE AMPLIFIER WAS DAMAGED AND DEFECTIVE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10312732 ↗MalfunctionApr 22, 2020Use of Device Problem; Use of Device Problem
THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9989097 ↗MalfunctionMar 13, 2020Use of Device Problem; Use of Device Problem
A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE NEEDS REPAIR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9829706 ↗MalfunctionJan 23, 2020Use of Device Problem; Use of Device Problem
A HEALTH ARE PROVIDER (HCP) REPORTED THAT A NERVE MONITORING DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9621472 ↗MalfunctionDec 26, 2019Use of Device Problem; Use of Device Problem
A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PREAMPLIFIER WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9521048 ↗MalfunctionDec 26, 2019Use of Device Problem; Use of Device Problem
A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PREAMPLIFIER WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9520996 ↗MalfunctionOct 8, 2019Use of Device Problem; Use of Device Problem
A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9166096 ↗MalfunctionFeb 20, 2019Unable to Obtain Readings; Failure to Sense; Unable to Obtain Readings; Failure to Sense
A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE STOPPED RESPONDING DURING OPERATION. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8353788 ↗MalfunctionApr 10, 2018Circuit Failure; False Negative Result; Device Stops Intermittently; Incomplete or Inadequate Connection; Circuit Failure; False Negative Result; Device Stops Intermittently; Incomplete or Inadequate Connection
THE CUSTOMER REPORTED AN INTERMITTENT ISSUE WITH THE MODULE AND SOME OF THE PORTS WERE NOT DETECTING. THE NERVE LOCATION WAS KNOWN, BUT THE DEVICE WAS NOT DETECTING IT. THE CUSTOMER WAS ABLE TO CONFIRM THE ISSUE BY REPLACING THE MODULE. ONCE REPLACED, THE SYSTEM WORKED FINE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7413277 ↗
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- Sedline® Seditation Monitor 9513Masimo Corporation · Full-montage Standard Electroencephalograph38 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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