Skip to content

Ameritus 232Recalls & reported problems

Kentec Medical, Inc. · OHMEDA GIRAFFE OMNI-BED COMPATIBLE TEMP.PROBE w/120P probe cover · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10817522010045), received between Oct 29, 2020 and Oct 29, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Sensing 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

Device problems

  • Device Sensing Problem1
  • Material Separation1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryOct 29, 2020Material Separation; Device Sensing Problem

    COMPLAINANT STATED THAT THE TEMPERATURE PROBE AND COVER SEPARATED FROM THE BABY AND CREATED A "TEMPERATURE EVENT". IF THE PROBE AND COVER ARE SEPARATED FROM THE PATIENT, IT CAN CAUSE THE TEMPERATURE SENSOR TO READ THE LOWER AMBIENT TEMPERATURES, WHICH THEN IN TURN, INCREASES THE TEMPERATURE WITHIN THE INCUBATOR, AS IT BELIEVES THE PATIENT IS TOO COLD. COMPLAINANT ALSO STATED THAT HE AND THE CLINICAL STAFF BELIEVE THAT THE ADHESIVE SEPARATED FROM THE PATIENT BECAUSE THEY WERE USING VERY HIGH LEVELS OF HUMIDITY IN THE INCUBATOR, AND DID NOT NECESSARILY BELIEVE IT WAS THE FAULT OF THE DEVICE. COMPLAINANT DECLINED TO PROVIDE ANY DETAILS REGARDING THE PATIENT STATUS OR ANY MEDICAL PROCEDURES THAT MAY HAVE BEEN A RESULT OF THE DEVICE FAILURE, BUT ONLY TO STATE THAT THERE WAS NO DEATH ASSOCIATED WITH THE INCIDENT. THERE HAVE BEEN NO RECENT COMPLAINTS FOR EITHER DEVICES, AND NO OTHER COMPLAINTS FOR THE LOT NUMBERS ASSOCIATED WITH THESE DEVICES. LOT NUMBER OF THE TEMPERATURE PROBE, CATALOG CODE 232, IS P-13879. LOT NUMBER OF THE TEMPERATURE PROBE COVER, CATALOG CODE 120, IS 070920. THE COMPLAINANT LISTED THE TEMPERATURE PROBE AS THE SUSPECT DEVICE, BUT IT APPEARS THAT IT WAS THE PROBE COVER

    Patient problems: Insufficient Information

    MAUDE report 10755095 ↗

Other Warmer, Infant Radiant devices

All Warmer, Infant Radiant devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.