Percussionaire F00012Recalls & reported problems
Percussionaire Corporation · Impulsator, 115V, English · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849436000389), received between Jan 24, 2024 and Feb 13, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Emits Odor” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K905236); 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
Recalls naming this device
- Aug 18, 2026Class IIOpen, Classified
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Z-3323-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Emits Odor1
- Infusion or Flow Problem1
- Pressure Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Oxygen Saturation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2024Pressure Problem; Pressure Problem
PER COMPLAINT RECEIVED BY THE CUSTOMER, WHILE IN USE ON THE PATIENT, THE CAREGIVER NOTED THAT THE DEVICE WOULD NOT PERCUSS/ROVIDE REQUIRED THERAPY UNTIL IT REACHED 28 PSI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18699247 ↗MalfunctionJan 24, 2024Infusion or Flow Problem; Infusion or Flow Problem
PER CUSTOMER COMPLAINT, THE IMPULSATOR AT HOME THERAPY DEVICE WAS IN USE ON PATIENT, WHEN IT STOPPED WORKING. IT WAS STATED BY THE CAREGIVER THAT A FUSE MAY HAVE MELTED. NO PATIENT HARM WAS STATED IN COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18573555 ↗InjuryJan 24, 2024Device Emits Odor; Device Emits Odor
PER COMPLAINT RECEIVED FROM THE CUSTOMER, WHILE PROVIDING TREATMENT TO THE CUSTOMER'S CHILD AT HOME, THE USER SMELLED A BURNT PLASTIC SMELL COMING FROM THE DEVICE. POST TREATMENT, THE CUSTOMER NOTICED THEIR CHILD'S OXYGEN LEVEL DROPPED SEVERLY, REQUIRING THE NEED TO CALL FOR EMERGENCY MEDICAL SERVICES. DURING A SECOND TREATMENT, OCCURRING THE FOLLOWING DAY, THE CUSTOMER NOTICED THEIR CHILD'S OXYGEN LEVEL DROPPED AGAIN. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS INCIDENT.
Patient problems: Low Oxygen Saturation
MAUDE report 18573321 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K905236. One submission often covers many models, so check the product and lot details in each record.
- Z-0208-2025 · Sep 16, 2024 · Open, ClassifiedPhasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Other Device, Positive Pressure Breathing, Intermittent devices
- Percussionaire P5Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent4 recalls2 reports
- Volara System M08473Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT3 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls3 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Volara System M08085Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
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 · each recall links to the FDA recall notice
- 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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