HUDSON RCI IPN049284Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704627735), received between Feb 12, 2021 and Mar 23, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Deliver” (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 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.

• InjuryMar 23, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED "THE PRODUCT WAS IN PLACE 3 DAYS WHEN THE RT WAS CALLED TO THE BEDSIDE OF A TRACH PATIENT WHO WAS COUGHING AND STRUGGLING TO EXPECTORATE. ON ARRIVAL, THE RT NOTED VERY DRY SECRETIONS WHICH WERE UNABLE TO BE SUCTIONED EASILY WITHOUT INSTILLING SALINE TO LOOSEN THEM. AT ONE POINT THE PATIENT COUGHED SO FORCEFULLY THAT THE TRACH SUTURES POPPED OUT. ON INSPECTION OF THE AEROSOL HUMIDITY, THE NEBULIZER WAS NOTED AS MALFUNCTIONING, I.E. NO AEROSOLIZATION OCCURRING DESPITE CORRECT SETUP OF THE EQUIPMENT AND A FULL WATER BOTTLE. HE TOOK THE NEBULIZER OFF THE BOTTLE, DIDN'T NOTE ANY OBVIOUS ISSUES WITH IT, RETHREADED IT ON A NEW BOTTLE AND SPIKED IT BUT IT WAS STILL NOT PRODUCING AEROSOL HUMIDITY". IT WAS REPORTED NO RESUSCITATION EFFORTS WERE REQUIRED. PATIENT CONDITION REPORTED TO BE "FINE".

  Patient problems: Airway Obstruction

  MAUDE report 11558040 ↗
• InjuryFeb 12, 2021Failure to Deliver; Failure to Deliver

  COMPLAINT WAS REPORTED "PATIENT HAS A TRACH WITH HIGH HUMIDITY TRACH MASK. PATIENT HAD A RESPIRATORY ARREST SECONDARY TO MUCUS PLUG. THIS HIGH HUMIDITY SET-UP DOES NOT PROVIDE THE SAME AMOUNT OF HUMIDITY AS THE PREVIOUS SET UP. CANNOT DETERMINE THAT THE PRODUCT CAUSED THE MUCUS PLUG AND RESPIRATORY ARREST, HOWEVER, MORE HUMIDIFICATION WOULD HAVE REDUCED THE RISK OF DEVELOPING A MUCUS PLUG". PATIENT HAD A RESPIRATORY ARREST SECONDARY TO MUCUS PLUG. THE TELEFLEX HUMIDITY SET-UP WAS CHANGED TO THE THERA-MIST LVN-HIGH FLOW (SMITHS MEDICAL)SET-UP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. PATIENT CONDITION UNKNOWN.

  Patient problems: Respiratory Arrest

  MAUDE report 11323753 ↗