Percussionaire P5 (UDI 00849436000501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849436000501), received between Oct 8, 2024 and Oct 9, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

4 FDA recall records name this device's identifier, 4 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 18, 2026Open, 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-3324-2026 · Root cause: Device Design · FDA record ↗

2. Aug 18, 2026Open, 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 · FDA record ↗

3. Aug 18, 2026Open, 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-3322-2026 · Root cause: Device Design · FDA record ↗

4. Aug 18, 2026Open, 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-3321-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Defective Component; Improper Chemical Reaction; Defective Component; Improper Chemical Reaction

  A COMPLAINT WAS RECEIVED ON (B)(6) 2024, FROM VA PALO ALTO MEDICAL CENTER REGARDING A BROWN LIQUID IN THE PHASITRON 5 TUBING. IT WAS STATED THAT THEY BELIEVE THE CIRCUIT WAS USED FOR 4 DAYS BEFORE NOTICING THE FLUID IN THE TUBING. NO ADVERSE REACTIONS HAVE BEEN REPORTED AT THIS TIME. THIS REPORT IS BEING COMPLETED RETROSPECTIVELY, AS IT HAS BEEN RECENTLY IDENTIFIED THAT THERE IS A POTENTIAL FOR HEALTH HAZARDS TO OCCUR DUE TO THIS ISSUE IF SPECIFIC PRODUCT LOTS ARE USED WITH CERTAIN MEDICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408650 ↗
• MalfunctionOct 8, 2024Defective Component; Improper Chemical Reaction; Defective Component; Improper Chemical Reaction

  A COMPLAINT WAS RECEIVED ON JULY 11, 2024, FROM TEXAS CHILDREN'S HOSPITAL REGARDING A BROWN LIQUID IN THE PHASITRON 5 TUBING. NO ADVERSE REACTIONS HAVE BEEN REPORTED AT THIS TIME. THIS REPORT IS BEING COMPLETED RETROSPECTIVELY, AS IT HAS BEEN RECENTLY IDENTIFIED THAT THERE IS A POTENTIAL FOR HEALTH HAZARDS TO OCCUR DUE TO THIS ISSUE IF SPECIFIC PRODUCT LOTS ARE USED WITH CERTAIN MEDICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402144 ↗

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, Classified
  Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy