Percussionaire F00001-C (REF S00002-C)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849436000020), received between Jul 2, 2024 and Jul 12, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

2 FDA recall records name this device's identifier, 2 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.

Recalls naming this device

1. 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-3322-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. 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-3321-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JUNE 13, 2024, A SENTEC EMPLOYEE WAS MADE AWARE OF AN ADVERSE EVENT WITH THE IPV-1C DEVICE OCCURRING AT (B)(6). LIMITED INFORMATION IS AVAILABLE ON THIS EVENT, AS THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION ON THE EVENT WHEN REQUESTED. IT WAS RELAYED TO A SENTEC EMPLOYEE VIA PHONE CALL THAT A PEDIATRIC PATIENT EXPERIENCED CARDIAC ARREST DUE TO APPLICATION ERRORS WITH THE DEVICE. IT WAS STATED THE EVENT WAS CAUSED BY CAPPING THE PHASITRON BREATHING CIRCUIT WHEN ADMINISTERING THE TREATMENT DIRECTLY TO THE AIRWAY. NO DATE OF WHEN THE EVENT OCCURRED WAS PROVIDED, AS WELL AS NO ADDITIONAL INFORMATION WAS PROVIDED ON PATIENT STATUS.

  Patient problems: Cardiac Arrest

  MAUDE report 19729296 ↗
• InjuryJul 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JUNE 13, 2024, A SENTEC EMPLOYEE WAS MADE AWARE OF AN ADVERSE EVENT WITH THE IPV-1C DEVICE OCURRING AT (B)(6). LIMITED INFORMATION IS AVAILABLE ON THIS EVENT, AS THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION ON THE EVENT WHEN REQUESTED. IT WAS RELAYED TO A SENTEC EMPLOYEE VIA PHONE CALL THAT A PEDIATRIC PATIENT EXPERIENCED CARDIAC ARREST DUE TO APPLICATION ERRORS WITH THE DEVICE. NO DATE OF WHEN THE EVENT OCCURRED WAS PROVIDED, AS WELL AS NO ADDITIONAL INFORMATION WAS PROVIDED ON PATIENT STATUS.

  Patient problems: Cardiac Arrest

  MAUDE report 19729132 ↗
• InjuryJul 2, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2024, CUSTOMER SERVICE WAS NOTIFIED OF AN ADVERSE EVENT THAT OCCURRED AT (B)(6) HOSPITAL. ON (B)(6) 2024, A RESPIRATORY THERAPIST WAS PROVIDING IPV THERAPY TO A PATIENT VIA IN-LINE CONNECTION ON A MECHANICAL VENTILATOR WITH AN IPV 1C DEVICE AND DID NOT SEE THE NORMAL CHEST WIGGLE EXPECTED ON THE PATIENT. IT WAS STATED THE BLUE CAP WAS PRESENT ON THE EXPIRATORY PORT OF THE PHASITRON BREATHING CIRCUIT AT THIS TIME. THE RESPIRATORY THERAPIST DECIDED TO PERFORM THE THERAPY DIRECTLY THROUGH THE PATIENT'S ARTIFICIAL AIRWAY AND DID NOT REMOVE THE BLUE CAP FROM THE PHASITRON CIRCUIT. IT WAS REPORTED THAT AFTER ABOUT 5 SECONDS OF CONNECTION, THE PATIENT IMMEDIATELY STARTED THRASHING AND VOMITED. THE PATIENT WAS REMOVED FROM THE THERAPY AND PLACED BACK ON THE VENTILATOR. THE PATIENT WENT INTO CARDIAC ARREST AND REQUIRED CHEST COMPRESSIONS TO RETURN TO A STABLE STATE. IT WAS LATER FOUND THROUGH A CHEST X-RAY THAT THE PATIENT DEVELOPED A BILATERAL PNEUMOTHORAX.

  Patient problems: Cardiac Arrest; Pneumothorax

  MAUDE report 19654852 ↗

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