Percussionaire F00002-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849436000037), received between Jan 24, 2024 and Nov 28, 2024 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Output Problem” (1 report).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathNov 28, 2024Use of Device Problem; Use of Device Problem

  ON NOVEMBER 1ST, A SENTEC REPRESENTATIVE WAS MADE AWARE OF A PATIENT DEATH AFTER USE OF AN IPV-2C DEVICE. THE RESPIRATORY THERAPY STAFF COMMUNICATED THAT THE PATIENT WAS A CRITICALLY ILL ADULT WITH MANY COMORBIDITIES, AND THUS WAS COMPLEX TO TREAT, AND EXTREMELY DIFFICULT TO VENTILATE. ADDITIONALLY IT WAS STATED DUE TO THE PATIENT'S COMORBIDITIES, THEY LIKELY WOULD HAVE SUCCUMBED TO THEIR CONDITIONS WITH OR WITHOUT ADMINISTERING IPV THERAPY IN ANY SETUP (IN-LINE OR DIRECT TO ET TUBE). THE PATIENT WAS STATED TO BE ON A VENTILATOR BUT REMOVED FROM THE VENTILATOR TO PROVIDE THE IPV TREATMENT. THE IPV TREATMENT WAS ADMINISTERED THROUGH THE PATIENTS ET TUBE DIRECTLY. THROUGH ADDITIONAL COMMUNICATIONS FROM THE SENTEC REPRESENTATIVE AND HOSPITAL STAFF, IT WAS STATED THAT THE EXPIRATORY PORT OF THE PHASITRON WAS OCCLUDED WITH THE IN-LINE VALVE BLUE CAP. THE PATIENT EXPERIENCED A PNEUMOTHORAX; MULTIPLE ATTEMPTS WERE MADE TO REVIVE THE PATIENT, HOWEVER, THE PATIENT ULTIMATELY PASSED AWAY. THE AMOUNT OF TIME THE PATIENT WAS SET UP WITH THE IPV TREATMENT AND SETTINGS USED WERE UNABLE TO BE CONFIRMED.

  Patient problems: Cardiac Arrest; Pneumothorax

  MAUDE report 20805843 ↗
• InjuryJun 13, 2024Pressure Problem; Pressure Problem

  ON (B)(6) 2024, PERCUSSIONAIRE WAS NOTIFIED THAT WHILE A PATIENT WAS BEING TREATED WITH THE IPV 2C THERAPY DEVICE, THE PATIENT EXPERIENCED BRADYCARDIA. TREATMENT WAS STOPPED IMMEDIATELY AND THE PATIENT WAS PLACED ON A VENTILATOR. AN IMMEDIATE X-RAY WAS TAKEN ON THE PATIENT AND IT AS DISCOVERED THAT THE PATIENT EXPERIENCED A LARGE PNEUMOTHORAX AND PNEUMOMEDIASTINUM. THE CUSTOMER INSPECTED THE UNIT OFF THE PATIENT AND THE IPV 2C DISPLAYED A SERIES OF ERROR CODES. WHEN THE CUSTOMER TESTED THE DEVICE WITH A NEW BREATHING CIRCUIT, THE DEVICE WOULD NOT GENERATE CONSISTENT PRESSURE.

  Patient problems: Pneumothorax

  MAUDE report 19532462 ↗
• InjuryJan 24, 2024Output Problem; Output Problem

  PER CUSTOMER FEEDBACK, WHILE PERFORMING IPV THERAPY ON A PATIENT, THE FREQUENCY HAD STOPPED AND A LOUD RUSH OF PRESSURE WAS HEARD FROM THE DEVICE. THE PATIENT WAS REMOVED FROM THE DEVICE. A SYSTEM FAILURE ERROR CODE APPEARED ON THE DEVICE, PROMPTING THE CUSTOMER TO CONTACT THE MANUFACTURER. THE PATIENT SUBSEQUENTLY DEVELOPED BRADYCARDIA AND DESATURATION. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO STABALIZE THE PATIENT. ONCE STABALIZED, THE PATIENT RECEIVED A CHEST X-RAY WHICH SHOWED BILATERAL TENSION PNEUMOTHORAX.

  Patient problems: Bradycardia; Low Oxygen Saturation; Pneumothorax

  MAUDE report 18573492 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED BY THE CUSTOMER STATING A PATIENT EXPERIENCED PNEUMOTHORAX AFTER USING THE IPV DEVICE. THIS WAS STATED TO BE DISCOVERED VIA X-RAY. IT WAS LATER CONFIRMED BY THE SITE THAT THE DEVICE DID NOT CAUSE THE PATIENT PNEUMOTHORAX. AN INVESTIGATION WAS STILL CONDUCTED ACCORDINGLY.

  Patient problems: Pneumothorax

  MAUDE report 18573159 ↗

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