RUSCH IPN915491Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704711717), received between Sep 10, 2021 and Aug 2, 2022 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionAug 2, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT "THE OPERATORS OBSERVED THE LARYNGOSCOPE HANDLE OVERHEATED WHILE WAITING THE BIRTH OF THE NEWBORN BABY THAT NEEDED TO BE INTUBATED." ALLEGDED EVENT OCCURRED DURING EQUIPMENT SERVICE. NO PATIENT INVOLVEMENT. HANDLE WAS NOT USED. DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145297 ↗
• MalfunctionAug 2, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT "THE OPERATORS OBSERVED THE LARYNGOSCOPE HANDLE OVERHEATED WHILE WAITING THE BIRTH OF THE NEWBORN BABY THAT NEEDED TO BE INTUBATED." ALLEGDED EVENT OCCURRED DURING EQUIPMENT SERVICE. NO PATIENT INVOLVEMENT. HANDLE WAS NOT USED. DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145278 ↗
• MalfunctionNov 2, 2021Temperature Problem; Temperature Problem

  IT WAS REPORTED, "DURING A PROCEDURE OF CHECKING DEVICES. THE PEDIATRIC NURSE CHECKED A LARYNGOSCOPE HANDLE TO MAKE SURE IT WAS PROPERLY WORKING. SHE SNAPPED THE HANDLE, DURING FEW SECONDS ON A BLADE. THE LIGHT PRODUCED WAS NOT VERY BRIGHT. SHE REMOVED THE BLADE AND DECIDED TO CHANGE THE BATTERIES OF THE HANDLE. WHEN SHE HANDLED THE BOTTOM OF THE LARYNGOSCOPE HANDLE TO UNSCREW IT AND REMOVE THE BATTERIES, SHE NOTICED THAT THIS AREA WAS BURNING HOT AND QUICKLY UNHANDED THE HANDLE. AFTER FEW MINUTES, IT WAS STILL HOT, BUT NO LONGER BURNING HOT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741067 ↗
• InjurySep 10, 2021Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT: "INVOLVED A PREMATURE NEWBORN BORN BABY (BORN ON (B)(6)) POSITIONED ON A BABYTHERM 8010 TABLE (SUPPLIER (B)(4)). ON (B)(6) 2021, THE BABY HAD A DETERIORATION OF HIS CLINICAL CONDITION (BRADYCARDIAS AND DESATURATIONS). THIS CLINICAL CONDITION REQUIRED HIS INTUBATION. THE INTERN DOCTOR HAD DIFFICULTIES TO PERFORM THE INTUBATION. THE LARYNGOSCOPE BLADE WAS LEFT WHILST STILL BEING SNAPPED ON THE HANDLE, DURING FEW MINUTES (2 TO 3 MINUTES), ON THE TABLE IN CONTACT OF THE CHILD. WHEN THE PEDIATRICIAN ARRIVED TO PERFORM THE INTUBATION, THE LARYNGOSCOPE HANDLE WAS HOT. THIS HANDLE WAS IN CONTACT WITH THE OUTER LEFT FOREARM OF THE CHILD. THE CHILD WAS SEDATED THEREFORE HE WAS NOT SENSITIVE TO PAIN. IT RESULTED IN A SIGNIFICANT BURN IN THE 2ND OR EVEN 3RD DEGREE ON THE OUTSIDE OF THE LEFT FOREARM OF THE CHILD. ON (B)(6) 2021, THE MEDICAL TEAM HAD DECIDED THAT IF THE SCAB COMES OFF, THEY WOULD MONITOR THE HEALING. OTHERWISE, OR IF THE BURN BECOMES INFLAMMATORY, THEN DECISION TO PERFORM A SKIN GRAFT. A CLOSE FOLLOW-UP BY PLASTIC SURGEONS IS CARRIED OUT". PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12452362 ↗