Percussionaire F00038-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849436000235), received between Jun 28, 2016 and Feb 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

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.

• MalfunctionFeb 13, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED BY THE END USER THAT ON JANUARY 2, 2020, THE CARE TEAM ARRIVED TO THE PATIENT'S LOCATION AND NOTICED THE PATIENT WAS IN A STATE OF EXTREMIS. WHEN ATTEMPTING TO USE THE VENTILATOR, IT FAILED PRIOR TO USE ON THE PATIENT. IT WAS STATED THE DEVICE WAS UNABLE TO REGISTER PRESSURE ON THE DEVICE MULTIMETER AND A LOUD LEAK WAS HEARD.THE PATIENT HAD TO BE MANUALLY VENTILATED DURING TRANSPORT TO THE HOSPITAL. A SECOND INCIDENT OCCURRED ON (B)(6) 2020, IN WHICH AGAIN THE SAME VENTILATOR DEVICE FAILED PRIOR TO USE ON A PATIENT IN THE SAME MANNER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18699241 ↗
• MalfunctionJan 24, 2024Infusion or Flow Problem; Noise, Audible; Infusion or Flow Problem; Noise, Audible

  PER THE CUSTOMER, THE RESPIRATORY THERAPIST ACCOMPANYING THE PATIENT WHILE IN TRANSPORT, INDICATED THAT THE DEVICE STARTED CHUGGING/HESITATING AND THEN STOPPED WORKING COMPLETELY. THE PATIENT HAD TO BE MANUALLY VENTILATED.

  Patient problems: Insufficient Information

  MAUDE report 18571872 ↗
• MalfunctionJun 28, 2016Leak/Splash; Device Operates Differently Than Expected

  POSSIBLE LEAK IN DEVICE. DEVICE USED A FULL M TANK IN 2 AND A HALF HOURS. BIOMED PERSONNEL DID A CHECK WITH A FLUKE DEVICE AND SAW SOME LEAKAGE WHILE THEY WERE RUNNING THE MACHINE. SHORTLY AFTER THIS, THE MACHINE WASN'T FUNCTIONING CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5757068 ↗

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.