Vital Signs™ S5000NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752145207), received between Aug 12, 2020 and Nov 9, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A FIVE-HOUR OLD PATIENT HAD AN INCREASED NEED OF OXYGEN, AND INTUBATION WAS DONE WITH VITAL SIGNS® ENDOTRACHEAL TUBE STYLET USED INSIDE THE TUBE.ON RETRACTION OF THE STYLET, SOME OF THE PLASTIC COATING FROM THE STYLET REMAINS INSIDE THE TUBE. THE TUBE IS IMMEDIATELY REMOVED . THE COATING WAS FOUND INSIDE THE TUBE AND NOT IN THE LUNGS. THE PATIENT HAD TO BE SEDATED AND INTUBATED AGAIN. WITH ACHIEVEMENT SUFFICIENT SPONTANEOUS RESPIRATION/IMPROVEMENT IN CONDITION, EXTUBATION WAS DONE, AND THE PATIENT WAS PLACED ON CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE). THE ANAESTHESIA WAS EXTENDED FROM 10 MIN TO 1.5 HOURS. TO FACILITATE THE SEDATION, BRIDION WAS GIVEN (A SUBSTANCE WITH WHICH THERE IS NOT MUCH EXPERIENCE IN CHILDREN UNDER 2 YEARS OF AGE). THE INCIDENT IS ASSESSED AS POTENTIALLY SERIOUS. BUT DID NOT HAVE ANY SERIOUS CONSEQUENCES. THE PATIENT IS FINE AND WAS DISCHARGED AFTER A MONTH OF HOSPITALIZATION WITH NO SIGNS OF FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102423 ↗
• MalfunctionAug 12, 2020Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS ENDOTRACHEAL TUBE STYLET WAS USED ON A BABY AND WHEN THE STYLET WAS PULLED OUT, THE CUSTOMER NOTICED THAT THE SHEATH WAS SEPARATED FROM THE STYLET. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10397035 ↗