Portex 100/120/200Recalls & reported problems
Icu Medical, Inc. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315012921), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Failure to Disconnect” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Disconnect1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 18, 2024Failure to Disconnect; Failure to Disconnect
THE INITIAL REPORTER MR. (B)(6)., FROM (B)(6) STATED THAT THEY HAD A LIFE-THREATENING SITUATION FOR A PATIENT. WHEN STARTING THE INTUBATION PROCESS (NOTED TO BE A "DIFFICULT INTUBATION"), THE DEVICE BECAME OCCUPIED AND STUCK WITHOUT THE POSSIBILITY OF REMOVING IT FROM THE TUBE. IT WAS STATED THAT MEDICAL INTERVENTION WAS NECESSARY. IT WAS NOT POSSIBLE TO PROVIDE MORE INFORMATION REGARDING THE SPECIFIC MEDICAL INTERVENTION THAT OCCURRED. THE CUSTOMER ALSO INFORMED THAT IT IS NOT POSSIBLE TO PROVIDE INFORMATION REGARDING WHERE THE DEATH OCCURRED, WHAT WAS THE STATUS OF THE PATIENT AND THEY DID NOT PROVIDE PATIENT¿S DETAILS. ONLY ONE SAMPLE OF THIS AFFECTED BATCH LOT WAS USED IN THIS EVENT. TWO PRODUCTS IN TOTAL WERE INVOLVED. THE HOSPITAL DOES NOT WANT TO PROVIDE THE INFORMATION ABOUT WHAT KIND OF TRACHEAL TUBE WAS USED. ACCORDING TO THE HEAD NURSE OF THE WARD, (B)(6), THE PERSON WHO PERFORMED THE INTUBATION WAS AN ANESTHETIST. HE DID NOT PROVIDE FURTHER INFORMATION ABOUT THE ANESTHETIST. IT IS UNKNOWN IF IT WAS THE FIRST TIME SHE PERFORMED AN INTUBATION. (B)(6) COMMENTED THAT IT WAS A DIFFICULT INTUBATION DURING AN EMERGENCY WITH AN OBESE PATIENT. THEY DID NOT USE ANY LUBRICANT DUE
Patient problems: Airway Obstruction
MAUDE report 18926068 ↗
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- Shiley 85865Covidien LP · STYLET, TRACHEAL TUBE3 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.