Portex 8500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688431219), received between Jan 12, 2018 and Jan 12, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K014115); they may or may not involve this specific model.

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

• InjuryJan 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED INDICATING THAT ABOUT 3-4 MINUTES INTO A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROCEDURE THIS 1ST RESPONSE MANUAL RESUSCITATOR BECAME DISCONNECTED FROM THE OXYGEN WALL REGULATOR. THIS CAUSED THE PATIENT'S OXYGEN SATURATION LEVEL (SPO2) TO DROP INTO THE 70 PERCENT RANGE AND THEIR HEART RATE TO DROP TO AROUND 30 BEATS PER MINUTE. THE OXYGEN WAS RECONNECTED AND THE PATIENT WAS VENTILATED WITH A MANUAL RESUSCITATOR. 10 MCG OF EPINEPHRINE WAS ADMINISTERED AND THE TEE PROBE WAS REMOVED. A CODE BLUE WAS CALLED FOR PULSELESS ELECTRICAL ACTIVITY ARREST. CPR WAS INITIATED WITH RETURN OF SPONTANEOUS CIRCULATION AFTER APPROXIMATELY 2-3 MINUTES. THE PROCEDURE WAS ABANDONED AND THE PATIENT WAS ADMITTED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT AND PLACED ON A VENTILATOR. IT WAS NOTED THAT NO ONE HAD PULLED ON THE TUBING CAUSING THE DISLODGEMENT FROM THE OXYGEN WALL REGULATOR DURING THE PROCEDURE. IT WAS ALSO NOTED THAT THE OXYGEN WALL REGULATOR WAS BEHIND THE CERTIFIED NURSING ASSISTANT MANAGING THE 1ST RESPONSE MANUAL RESUSCITATOR THUS THE DISLODGEMENT WAS NOT IMMEDIATELY RECOGNIZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest; Hypoxia; Low Blood Pressure/ Hypotension

  MAUDE report 7185403 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014115. One submission often covers many models, so check the product and lot details in each record.

• Z-0810-03 · Nov 15, 2002 · Terminated
  Portex 1st Response Adult Manual Resuscitators Ref: 8503P
• Z-0808-03 · Nov 15, 2002 · Terminated
  Portex 1st Response Adult Manual Resuscitators Ref: 8506P
• Z-0809-03 · Nov 15, 2002 · Terminated
  Portex 1st Response Adult Manual Resuscitators Ref: 8500P