Percussionaire F00008-1 (REF S00018-1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00849436000044), received between Jan 24, 2024 and Dec 16, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K905235); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  ON (B)(6) 2025, IT WAS REPORTED THAT WHILE A VDR-4 DEVICE WAS IN USE ON A PATIENT, THE CUSTOMER REPRESENTATIVE HAD DIFFICULTY ADJUSTING THE CONTROLS ON THE VDR-4 VENTILATOR. IT WAS COMMUNICATED THAT THE DEVICE CONTROLS WERE UNRESPONSIVE AND THE VENTILATOR CONTINUOUSLY ALARMED. THE VENTILATOR HAD TO BE EXCHANGED TO AVOID ANY FURTHER PATIENT DECLINE. DUE TO THE UNINTENDED MEDICAL INTERVENTION, THIS REPORT IS BEING SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821413 ↗
• MalfunctionNov 14, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  A COMPLAINT WAS RECEIVED BY A CUSTOMER USING A VDR-4 STATING THAT WHILE THE DEVICE WAS BEING USED ON A PATIENT, THE DEVICE'S SECONDARY DISCONNECT ALARM FAILED TO ALARM. IT WAS CONFIRMED BY THS CUSTOMER THAT THE ALARM FUNCTION WAS WORKING PROPERLY DURING THE PRE-USE CHECK. NO PATIENT HARM OR INJURY WAS REPORTED DUE TO THIS FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691535 ↗
• MalfunctionJan 25, 2024Display or Visual Feedback Problem; Infusion or Flow Problem; Display or Visual Feedback Problem; Infusion or Flow Problem

  PER THE CUSTOMER COMPLAINT, WHILE THE DEVICE WAS IN USE ON A PATIENT, IT WAS STATING THE VENTILATOR DEVICE WAS NOT FUNCTIONING CORRECTLY, AS WELL AS NOT DISPLAYING ACCURATE PATIENT DATA. THE PATIENT WAS STATED TO BE STABLE AND NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579916 ↗
• MalfunctionJan 24, 2024Device Alarm System; Device Alarm System

  PER CUSTOMER COMPLAINT RECEIVED, WHILE THE PATIENT WAS USING THE VDR DEVICE FOR VENTILATION, THE PATIENT EXPERIENCED DESAT. THE BLENDER ALARM SOUNDED. THE RESPIRATORY THERAPIST ALSO NOTICED THE VENT PRESSURE DECREASING. THE PATIENT WAS MOVED TO ANOTHER VENTILATOR. NO PATIENT HARM REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18576305 ↗
• MalfunctionJan 24, 2024Improper Flow or Infusion; Improper Flow or Infusion

  PER CUSTOMER FEEDBACK, A VDR VENTILATOR FAILED WHILE IN USE ON A PATIENT. IT WAS STATED BY THE CUSTOMER THAT NO OXYGEN WAS BEING DELIVERED TO THE PATIENT. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573398 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K905235. One submission often covers many models, so check the product and lot details in each record.

• Z-0960-2025 · Dec 23, 2024 · Open, Classified
  VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR
• Z-0693-2024 · Mar 28, 2023 · Open, Classified
  Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
• Z-0259-2024 · Sep 14, 2020 · Completed
  Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.