Percussionaire A50605-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00849436000334), received between Jan 24, 2024 and Nov 4, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 12, 2023Open, Classified

   Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user

   Z-0637-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Improper Flow or Infusion; Improper Flow or Infusion

  THIS EVENT IS BEING SUBMITTED RETROSPECTIVELY DUE TO RECENT REASSESSMENT OF THE COMPLAINT. A COMPLAINT WAS RECEIVED BY THE CUSTOMER STATING WHEN SETTING UP THE PHASITRON CIRCUIT, THE CIRCUIT WOULD AUTOMATICALLY GO TO CERTAIN PRESSURE AND NOTHING COULD BE DONE TO CORRECT THE ISSUE. THE CUSTOMER REPLACED THE CIRCUIT AND DISCOVERED THE SECOND EXPERIENCED THE SAME ISSUE. NO PATIENT HARM OR INJURY WAS REPORTED. THIS WAS FOUND PRIOR TO PATIENT USE. HOWEVER, AS THERE WAS A MALFUNCTION TO A LIFE-SUSTAINING PRODUCT WITH THE POSSIBILITY OF HARM IS DEFECTIVE PRODUCT IS USED, THIS EVENT IS BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598366 ↗
• MalfunctionOct 25, 2024Improper Flow or Infusion; Improper Flow or Infusion

  THIS EVENT IS BEING SUBMITTED RETROSPECTIVELY DUE TO RECENT REASSESSMENT OF THE COMPLAINT. IT WAS COMMUNICATED BY THE CUSTOMER THAT WHILE TRANSPORTING A CRITICALLY ILL INFANT, THE PHASITRON BREATHING CIRCUIT WOULD NOT ALLOW PRESSURE TO BE LOWERED TO A THERAPEUTIC RANGE. NO ADVERSE EVENT WAS REPORTED BY THE CUSTOMER. AS THERE WAS A MALFUNCTION OF A LIFE-SUSTAINING DEVICE AND SUBSEQUENTLY A DELAY IN TREATMENT TO A CRITICALLY ILL PATIENT, THIS EVENT IS BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537249 ↗
• InjuryJan 24, 2024Inaccurate Delivery; Infusion or Flow Problem; Inaccurate Delivery; Infusion or Flow Problem

  PER CUSTOMER COMPLAINT, WHILE THE PHASITRON BREATHING CIRCUIT WAS USED IN CONJUNCTION WITH THE BRONCHONTRON TRANSPORT VENTILATOR, A MALFUNCTION OCCURRED IN WHICH THE DEVICE DELIVERED A HIGHER THAN INTENDED AMOUNT OF PRESSURE TO THE PATIENT. THIS RESULTED IN THE PATIENT EXPERIENCING PNEUMOMEDIASTINUM, CONTRIBUTING TO PATIENT REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: Pneumothorax

  MAUDE report 18573574 ↗
• MalfunctionJan 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  PER CUSTOMER COMPLAINT, A NEW PHASITRON CIRCUIT WAS SET UP, READY TO BE USED BUT WOULD NOT GENERATE A PULSATILE FLOW OR FREQUENCY CONSISTENTLY. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18573322 ↗
• InjuryJan 24, 2024Improper Flow or Infusion; Improper Flow or Infusion

  PER THE COMPLAINT, ENOUGH PRESSURE WAS UNABLE TO BE GENERATED THROUGH THE PHASITRON DEVICE. THE PATIENT EXPERIENCED MILD DESAT (DROP IN OXYGEN LEVELS) WHEN THE CUSTOMER WAS ATTEMPTING TO TRANSITION TO ANOTHER PHASITRON.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18573267 ↗

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.