N/A (REF MAX-N)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885825014322), received between Sep 27, 2017 and Jun 30, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Temperature 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT AFTER AN OPERATIVE SURGERY, THE PATIENT RECEIVED ANTI-INFLAMMATORY TREATMENT FOR A BURN AT THE COMPLAINT DEVICE'S ATTACHMENT SITE ON THEIR FOOT. THERE WAS NO OTHER PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Burn(s); Inflammation

  MAUDE report 17243237 ↗
• InjuryFeb 22, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT ON 13TH OF JANUARY, THE PATIENT UNDERWENT SURGERY - BILATERAL TONSILLECTOMY, ADENOIDECTOMY AND BILATERAL SUBMUCOUS RESECTION OF INFERIOR TURBINATES, AND THAT A BURN WAS NOTICED UPON REMOVAL OF THE COMPLAINT DEVICE FROM THE LEFT INDEX FINGER IN THE RECOVERY ROOM. SUBSEQUENT TO DISCHARGE, IT WAS REPORTED THAT THE BURN THEN BLISTERED AND RUPTURED, UPON WHICH ANTIBIOTICS WERE PRESCRIBED. THE WOUND THEN GOT INFECTED, SO THE PATIENT WENT TO THE ER WHERE THE WOUND WAS REPORTED TO HAVE BEEN EXPLORED. THE PHYSICIAN SAW THE PATIENT AGAIN ON THE 24TH OF JANUARY AND REPORTED THAT THE WOUND IS ON THE DISTAL JOINT OF THE LEFT INDEX FINGER AND IS HEALING. THERE WAS NO EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 16418644 ↗
• InjuryNov 16, 2017Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A PULSE OXIMETER CORD ON AN INFANT WAS FOUND TO HAVE EXPOSED WIRES. THE EVENT REPORT TYPE WAS REPORTED TO BE A SERIOUS INJURY AND IT WAS REPORTED THAT INTERVENTION WAS REQUIRED. HOWEVER, THE EVENT WAS NOT REPORTED TO BE AN ADVERSE EVENT. THE REPORTED EVENT WAS SUBMITTED THROUGH A MEDWATCH FORM AND NO FOLLOW UP IS POSSIBLE AS NO FACILITY OR CONTACT INFORMATION WAS PROVIDED AND THE REPORTED LOT NUMBER WAS SHIPPED TO MULTIPLE FACILITIES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Injury

  MAUDE report 7039113 ↗
• InjurySep 27, 2017Break

  OXYGEN SENSOR CORD ON INFANT FOUND TO HAVE EXPOSED WIRES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6900067 ↗