Percussionaire F00008-1 (REF S00018-2)Recalls & reported problems

Percussionaire Corporation · VDR4 without Monitron II · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849436000556), received between Nov 28, 2024 and Nov 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Increase in Pressure” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Increase in Pressure1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionNov 28, 2024Increase in Pressure; Increase in Pressure
PERCUSSIONAIRE WAS NOTIFIED ON NOVEMBER 1 REGARDING A POTENTIAL MALFUNCTION WITH A VDR VENTILATOR. IT WAS REPORTED BY THE CUSTOMER THAT THE VDR WAS MAKING UNUSUAL NOISES WHILE IN USE ON A PATIENT. THE VDR WAS CLOSELY MONITORED AFTER THIS INITIAL OBSERVATION. SHORTLY AFTER, IT WAS NOTICED ON THE VDR MONITOR THAT THE DISPLAYED PRESSURE ON THE OSCILLATORY CPAP WOULD STOP OSCILLATING AND UNEXPECTEDLY INITIATE A MANUAL BREATH AUTOMATICALLY. THE PRESSURE THEN ROSE INTO THE 70S BRIEFLY, AND THEN RETURNED TO THE OSCILLATORY CPAP MODE. THE CUSTOMER COMMUNICATED THAT THERE WAS AN AUDIBLE INCREASE IN FLOW, WHICH SUGGESTED THE PRESSURE WAS DELIVERED TO THE PATIENT. THE DEVICE WAS THEN REMOVED FROM THE PATIENT. THE PATIENT WAS CONFIRMED TO HAVE NO ADVERSE REACTIONS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20805839 ↗

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.

Device details

UDI-DI	`00849436000556`
Brand	Percussionaire
Model	F00008-1
Catalog no.	S00018-2
Company	Percussionaire Corporation
Product code	CBK · Ventilator, Continuous, Facility Use
Class	Class 2
FDA submission	K905235
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 3, 2019

Device type (GMDN): Stationary pneumatic high-frequency ventilator

A pneumatically-powered automatic cycling machine designed for static use and intended to assist or control alveolar ventilation using a frequency that is considerably higher than the physiological breathing rate and a tidal volume less than or equal to the anatomic dead space. The device will typically function independently or may be used in conjunction with an intensive care ventilator to superimpose its high frequency percussive ventilation on top of a normal ventilation frequency. It is typically used in critical care situations on patients with respiratory disease requiring ventilatory assistance, typically through an artificial airway [e.g., endotracheal (ET) tube or tracheostomy].

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All Ventilator, Continuous, Facility Use devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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