SedLine® Patient Cable 3637Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843997007955), received between Jul 23, 2017 and Jul 27, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Stops Intermittently” (1 report).
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.
Most reported problems
Device problems
- Device Stops Intermittently1
- Loose or Intermittent Connection1
- No Display/Image1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED INTERMITTENT READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7729306 ↗MalfunctionApr 2, 2018Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED SIGNAL CUTTING IN AND OUT. TRACKING EVERY 10 MINUTES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7391249 ↗MalfunctionJul 23, 2017No Display/Image; No Display/Image
THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "DSA DISPLAY SHOWED RED LINES ACROSS THE FIELD, NOT HAVING SEEN THIS PATTERN BEFORE, PHYSICIAN CALLED ME IN THE ROOM TO VERIFY THE INFORMATION, I GUIDED HIM TO CHECK LEAD PLACEMENT, AND PROCEEDED TO EXCHANGE THE PATIENT CABLE, AT WHICH POINT THE PROBLEM WAS RESOLVED. PICTURE ATTACHED. TROUBLESHOOTING STEPS: THE PATIENT SENSOR WAS CHANGED, LEAD PLACEMENT WAS CONFIRMED, BUT, SAME BAD RESULTS. DSA CONTINUED TO SHOW ALTERED. CHANGED PATIENT CABLE, AND DSA SHOWED MORE IN ACCORDING TO CLINICAL SCENARIO. NEVER CHANGED THE SEDLINE MODULE, BUT CHANGING THE SEDLINE PATIENT CABLE SOLVED THE ISSUE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6734965 ↗
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- Seer Home SM-03-8001-INTSeer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
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- Sedline® Seditation Monitor 9513Masimo Corporation · Full-montage Standard Electroencephalograph38 reports
- NA DAQ916Medtronic Xomed, Inc. · Full-montage Standard Electroencephalograph27 reports
- SedLine™ EEG Sensor 2479Masimo Corporation · Full-montage Standard Electroencephalograph14 reports
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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