Xltek 2003011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382830023764), received between May 23, 2022 and Aug 15, 2023 — classified as 3 malfunctions.

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

• MalfunctionAug 15, 2023Failure to Power Up; Power Problem; Failure to Power Up; Power Problem

  PART EMBLETTA MPR PG -: SPO2 NOT RECORDING ON MPR DEVICE. THE PULSE OXIMETER DURING PATIENT'S HOME SLEEP STUDY FAILED TO TURN ON FOR THE PATIENT AT HOME. PATIENT DID WEAR THE HOME SLEEP TEST, BUT BECAUSE THERE WAS NO OXIMETRY READING THE PATIENT HAD TO REPEAT THE TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547562 ↗
• MalfunctionFeb 28, 2023Accessory Incompatible; Accessory Incompatible

  EMBLETTA MPR PG - PATIENT HAD BURNING/BLISTERS BETWEEN ELECTRODES USED WITH MPR SYSTEM. NO MEDICAL INTERVENTION WAS REQUIRED TO TREAT SKIN BURNS/BLISTERS.

  Patient problems: Blister

  MAUDE report 16452459 ↗
• MalfunctionMay 23, 2022Excessive Heating

  THE PATIENT COMPLAINED OF RECEIVING A ELECTRODE BURN DURNING EXAM. NO FURTHER ACTION WAS TAKEN. DOCTOR APPLIED DRESSING TO THE BURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470600 ↗