BIS PMB4000DOCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521808300), received between Jan 30, 2025 and Jun 16, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Failure to Run on Battery; Temperature Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE MONITOR AND DOCKING STATION WOULD NOT CHARGE, BUT UPON INSPECTION, IT WAS FOUND THAT THE BOTTOM OF THE DOCKING STATION WHERE THE CHARGER WAS CONNECTED BURNT. NO SMOKE WAS SEEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523251 ↗
• MalfunctionJun 27, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE WAS REPORTED TO HAVE DISCHARGED DUE TO BEING UNPLUGGED. AN ATTEMPT TO INSERT THE POWER ADAPTER INTO THE DOCKING STATION FOR CHARGING REVEALED THAT THE ADAPTER WOULD NOT STAY SECURELY IN PLACE. UPON INSPECTING THE DOCKING STATION, IT WAS DISCOVERED THAT A MINOR INCIDENT, CABLE BURN, HAD OCCURRED INSIDE THE DOCKING STATION. TO ADDRESS THIS, THE POWER CABLE WAS SECURED WITH CABLE TIES TO MINIMIZE STRAIN AT THE POINT OF INSERTION INTO THE DOCKING STATION. ADDITIONALLY, A 12V POWER SUPPLY UNIT WAS IMPLEMENTED BETWEEN THE 230V POWER SOURCE AND THE DOCKING STATION TO ACT AS A SAFEGUARD. IN THE EVENT OF A POWER SURGE, THIS UNIT WOULD BE MORE LIKELY TO SUSTAIN DAMAGE RATHER THAN THE DOCKING STATION ITSELF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347716 ↗
• MalfunctionJun 3, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY (HIP ENDOPROSTHESIS) WITH TIVA ANESTHESIA, THE CUSTOMER NOTICED A BURNT SMELL. UPON INSPECTION, FOUND THAT THE CONNECTION BETWEEN THE POWER SOURCE AND THE DOCKING STATION HAD STARTED TO MELT. BEFORE ANY FIRE OCCURRED, THE MONITOR WAS IMMEDIATELY SWITCHED OFF AND DISCONNECTED FROM THE MAINS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131312 ↗
• MalfunctionJan 30, 2025Insufficient Heating; Temperature Problem; Insufficient Heating; Temperature Problem

  IT WAS REPORTED THAT A DOCKING STATION WAS HOT TO THE TOUCH, WITH A TEMPERATURE NOTED TO BE OVER 117 DEGREES WAS OVER THE LIMIT BASED ON THE MANUAL, DURING PRE-OP/PREPARING FOR USE. IT WAS REPORTED THAT THERE WAS NO SMOKE AND FLAME SEEN. AFTER REMOVING THE TABLET FROM THE DOCKING STATION, THE DOCKS REMAINED HOT, BUT THE TABLETS WERE WITHIN THE NORMAL RANGE. TROUBLESHOOTING STEPS INCLUDED SWAPPING TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272815 ↗