LABSYSTEM™ PRO M0042002022R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729885887), received between Jun 23, 2020 and Aug 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Power Conditioning 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE A LABSYSTEM PRO AMPLIFIER WAS SELECTED FOR USE. THE AMPLIFIER WOULD NOT TURN ON AND IT APPEARED TO BE DUE TO A POWER ISSUE. THE PROCEDURE WAS CANCELLED, THE SEDATION STATUS OF THE PATIENT WAS NOT PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THE AMPLIFIER WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472172 ↗
• MalfunctionJun 23, 2020Power Conditioning Problem; Power Conditioning Problem

  IT WAS REPORTED THAT DUE TO A DEVICE MALFUNCTION THE PROCEDURE HAD TO BE CANCELLED. A LAB SYSTEM PRO WAS SELECTED FOR USE. THERE WAS NOISE ON THE ECG WHICH MADE THE PROCEDURE DIFFICULT TO PERFORM THEREFORE THE PROCEDURE HAD TO BE CANCELLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10185240 ↗
• MalfunctionJun 23, 2020Power Conditioning Problem; Power Conditioning Problem

  IT WAS REPORTED THAT DUE TO A DEVICE MALFUNCTION THE PROCEDURE HAD TO BE CANCELLED. A LAB SYSTEM PRO WAS SELECTED FOR USE. THERE WAS NOISE ON THE ECG WHICH MADE THE PROCEDURE DIFFICULT TO PERFORM THEREFORE THE PROCEDURE HAD TO BE CANCELLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183799 ↗