PNEUMOCLEAR FM300 (UDI 04056702003456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04056702003456), received between Oct 24, 2018 and Jan 3, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT EXPERIENCED BRADYCARDIA REQUIRING CPR AND CONVERSION PROCEDURE WAS CONVERTED TO OPEN SURGERY.

  Patient problems: Cardiac Arrest

  MAUDE report 21069322 ↗
• MalfunctionNov 13, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679036 ↗
• InjurySep 5, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 17687320 ↗
• InjurySep 5, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 17687218 ↗
• InjuryJan 13, 2023Pressure Problem; Pressure Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162181 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "DURING THE PROCEDURE WITH REF: (B)(4) SN: (B)(4) THERE WAS A CARDIAC ARREST. ACCORDING TO MEDICAL PERSONNEL IT WAS CAUSED BY THE MEDICAL DEVICE. VITAL FUNCTIONS HAVE BEEN RESTORED."

  Patient problems: Cardiac Arrest

  MAUDE report 14948587 ↗
• InjuryJun 30, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED CARDIAC ARREST. VITAL FUNCTIONS HAVE BEEN RESTORED.

  Patient problems: Cardiac Arrest

  MAUDE report 14877701 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN INJURY TO THE PATIENT'S LIVER. THE INJURY WAS REPAIRED.

  Patient problems: Liver Laceration(s)

  MAUDE report 8002683 ↗