Drive P-224Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383274508), received between Aug 27, 2021 and Aug 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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.

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.

• MalfunctionAug 27, 2021Component Missing; Component Missing

  WE ARE SUBMITTING THIS REPORT IN RESPONSE TO MEDWATCH FILE NUMBER (B)(4). THE DEVICE WAS NOT BEING USED ON PATIENT. A HEALTHCARE WORKER IDENTIFIED THE MISSING MEMBRANE UPON VISUAL INSPECTION OF THE DEVICE AND DISPOSED OF DEVICE PRIOR TO BEING USED. DESCRIBE POTENTIALLY HAZARDOUS EVENT AND POTENTIAL ADVERSE HEALTH OUTCOME IF APPLICABLE: AN OXYMIZER PENDANT WITH MISSING RESERVOIR MEMBRANE WILL ALLOW SOME VOLUME OF OXYGEN FROM THE SUPPLY SOURCE TO LEAK OUT OF THE RESERVOIR VENTS INTO THE AMBIENT ENVIRONMENT. USE OF AN OXYMIZER PENDANT MISSING THE MEMBRANE MAY CAUSE A REDUCTION IN THE NET AMOUNT OF SUPPLEMENTAL OXYGEN DELIVERED TO THE PATIENT. A REDUCED AMOUNT OF OXYGEN TO THE PATIENT MAY RESULT A LOWER THAN ANTICIPATED BLOOD OXYGEN LEVEL. DESCRIBE ANY FACTORS RELATED TO THE OCCURRENCE OF POTENTIALLY HAZARDOUS EVENTS SUCH AS DEVICE OR OTHER PRODUCT RELATED FACTORS OR USER RELATED FACTORS THAT PUT THE POPULATION AT GREATER RISK. THE PRESENCE OF FIRE OR AN IGNITION SOURCE, SUCH AS A PATIENT SMOKING WHILE USING OR NEAR THE DEVICE MAY LEAD TO PERSONAL INJURY AND/OR PROPERTY DAMAGE. A LOWER THAN ANTICIPATED AMOUNT OF DELIVERED OXYGEN TO A PATIENT MAY RESULT IN MILD, REVERSIBLE CONDITIONS, S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377907 ↗