BIS PMB4000ACBLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521808317), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Temperature Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 22347981 ↗