LABSYSTEM™ PRO M00420020810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729996934), received between May 31, 2022 and May 31, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2022Use of Device Problem; Communication or Transmission Problem; Use of Device Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE LS PRO RECORDING SYSTEM THE WAS NOT CORRECTLY MEASURING THE BLOOD PRESSURE OF THE PATIENT. AT THE START OF THE PROCEDURES THE BLOOD PRESSURE WAS NORMAL AND THEN DURING THE PROCEDURE THE BLOOD PRESSURE WOULD BECOME UNDERESTIMATED. WHEN THEY CHECKED THE CALIBRATED ZERO WAS NOT CORRECT AND WAS LOWER THAN EXPECTED AND NEEDED TO BE RESET. ONCE THE RESET HAS BEEN PERFORMED THE PROCEDURES WERE COMPLETED SUCCESSFULLY. DURING THESE PROCEDURES THERE WERE NO OTHER SYSTEMS IN USE TO MONITOR THE VITAL SIGNS OF THE PATIENT. THE RECORDING SYSTEM IS NOT EXPECTED TO BE RETURNED AS IT IS GOING TO BE REPAIRED ON SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14553560 ↗
• MalfunctionMay 31, 2022Use of Device Problem; Communication or Transmission Problem; Use of Device Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE LS PRO RECORDING SYSTEM THE WAS NOT CORRECTLY MEASURING THE BLOOD PRESSURE OF THE PATIENT. AT THE START OF THE PROCEDURES THE BLOOD PRESSURE WAS NORMAL AND THEN DURING THE PROCEDURE THE BLOOD PRESSURE WOULD BECOME UNDERESTIMATED. WHEN THEY CHECKED THE CALIBRATED ZERO WAS NOT CORRECT AND WAS LOWER THAN EXPECTED AND NEEDED TO BE RESET. ONCE THE RESET HAS BEEN PERFORMED THE PROCEDURES WERE COMPLETED SUCCESSFULLY. DURING THESE PROCEDURES THERE WERE NO OTHER SYSTEMS IN USE TO MONITOR THE VITAL SIGNS OF THE PATIENT. THE RECORDING SYSTEM IS NOT EXPECTED TO BE RETURNED AS IT IS GOING TO BE REPAIRED ON SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552799 ↗