Percussionaire F00007-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00849436000068), received between Jan 24, 2024 and Jun 18, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (10 reports).

1 FDA recall record name this device's identifier.

2 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.

Recalls naming this device

1. Sep 14, 2020Class IICompleted

   Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.

   Z-0259-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026No Display/Image

  MONITRON SCREEN WENT BLANK WHILE IN USE ON A PATIENT. THE MONITRON IS USED IN COMBINATION WITH A VDR VENTILATOR. THE VENTILATOR STILL FUNCTIONED AS INTENDED AND THERE WAS NO IMPACT TO THE PATIENT. NO HARM WAS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548764 ↗
• MalfunctionJan 9, 2026No Display/Image

  PER CUSTOMER COMPLAINT RECEIVED ON (B)(6) 2026, THE MONITRON DISPLAY, WHICH IS USED WITH THE VDR-4 VENTILATOR, EXPERIENCED A WHITE SCREEN ON THE THIRD DAY OF PATIENT USE. THE CUSTOMER RESTARTED THE DEVICE A FEW TIMES, HOWEVER, THE ISSUE WOULD NOT RESOLVE ITSELF. THE MULTIMETER ON THE VDR DEVICE WAS ALSO NOT DISPLAYING ANY DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021250 ↗
• MalfunctionDec 16, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2025, IT WAS COMMUNICATED BY THE CUSTOMER THAT THE MONITRON DEVICE MALFUNCTIONED WHILE IN USE ON A PATIENT. IT WAS STATED THAT THE TRANSDUCERS WERE FAILING AND PROVIDING INACCURATE VALUES ON THE DISPLAY. NO PATIENT HARM WAS REPORTED. HOWEVER, AS THE MONITRON DEVICE IS USED WITH THE VDR-4 VENTILATOR, A LIFE-SUPPORTING DEVICE, THIS EVENT IS BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821414 ↗
• MalfunctionFeb 29, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  PER COMPLAINT RECEIVED BY THE CUSTOMER, WHILE IN USE ON A PATIENT IN CONJUNCTION WITH A VENTILATOR, THE MONITRON DISPLAY WAS FREEZING CONSISTENTLY. THE CUSTOMER STATED TO RESET THE DEVICE BY TURNING IT OFF AND THEN BACK ON. HOWEVER, THE DEVICE STILL RESULTED IN A SCREEN FREEZE. THE MONITRON AND VENTILATOR WAS SWAPPED FOR ANOTHER DEVICE AND THE ISSUE WAS STATED TO BE RESOLVED. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806891 ↗
• MalfunctionJan 30, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  PER COMPLAINT RECEIVED BY THE CUSTOMER, WHILE IN USE ON A PATIENT IN CONJUNCTION WITH A VENTILATOR, THE MONITRON DISPLAY WAS FREEZING EVERY COUPLE OF HOURS. NO PATIENT HARM OR INJURY WAS REPORTED. SYSTEM HAD TO BE SWAPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606444 ↗
• MalfunctionJan 30, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  PER COMPLAINT RECEIVED BY THE CUSTOMER, WHILE IN USE ON A PATIENT IN CONJUNCTION WITH A VENTILATOR, THE MONITRON DISPLAY WAS FREEZING. THE DEVICE WOULD ONLY RESET IF TURNED OFF AND TURNED BACK ON. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606439 ↗
• MalfunctionJan 30, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  PER CUSTOMER COMPLAINT RECEIVED BY PERCUSSIONAIRE DISTRIBUTOR, WHILE IN USE IN CONJUNCTION WITH A VENTILATOR ON A PATIENT AT THE TIME OF THE INCIDENT, THE MONITRON SCREEN WAS STATED TO BE FREEZING EVERY 4-5 HOURS AND NOT DISPLAYING ACCURATE INFORMATION. THE RESPIRATORY THERAPISTS HAD TO RELY ON THE MANOMETER. THE MONITRON/VDR WERE SWAPPED OUT FOR A FUNCTIONING SYSTEM. NO PATIENT HARM OR INJURY STATED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606254 ↗
• MalfunctionJan 29, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  PER PRODUCT COMPLAINT, WHILE THE MONITRON WAS IN USE WITH A VENTILATOR ON A PATIENT, THE SCREEN WAS NOTED TO FREEZE. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602589 ↗
• MalfunctionJan 25, 2024No Display/Image; No Display/Image

  PER CUSTOMER COMPLAINT, THE MONITRON WAS UNPLUGGED WHILE ON AND IN USE WITH A VDR VENTILATOR ON A PATIENT. IT WAS PLUGGED INTO ANOTHER OUTLET AND THE SCREEN TURNED WHITE AND COULD NOT BE RESET. THE SYSTEM WAS REPLACED WITH ANOTHER SYSTEM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580360 ↗
• MalfunctionJan 25, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  PER A COMPLAINT RECEIVED BY THE CUSTOMER, THE MONITRON DISPLAY, WHCH IS CONNECTED TO A VENTILATOR, FROZE WHILE IN USE ON A PATIENT. IT WAS STATED THAT THE VENTILATION WAS NOT IMPACTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580272 ↗
• MalfunctionJan 24, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  PER CUSTOMER COMPLAINT, WHILE IN USE ON A PATIENT, BOTH THE MONITRON SCREEN AND VDR VENTILATOR DISPLAY FROZE. THE END USER ATTEMPTED TO RESET THE DISPLAYS, BUT BOTH AGAIN FROZE. NO PATIENT HARM WAS STATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576341 ↗
• MalfunctionJan 24, 2024No Display/Image; No Display/Image

  PER CUSTOMER COMPLAINT, WHILE THE MONITRON DISPLAY WAS IN USE WITH A VDR VENTILATOR, THE SCREEN TURNED WHITE. THE END USER ATTEMPTED TO TURN THE DEVICE OFF AND BACK ON TO RESENT, BUT THERE WAS NO CHANGE. THE MONITRON AND VDR WERE REPLACED WITH A FUNCTIONING DISPLAY AND VENTILATOR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576325 ↗
• MalfunctionJan 24, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  PER CUSTOMER COMPLAINT, THEIR MONITRON SCREEN, USED IN CONJUNCTION WITH A VENTILATOR, WENT BLANK WHILE ON A PATIENT. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573530 ↗
• MalfunctionJan 24, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  PER CUSTOMER FEEDBACK, THE MONITRON DISPLAY WAS IN USE WITH A VDR VENTILATOR AND THE SCREEN WENT BLANK WHILE BEING USED ON PATIENT. NO PATIENT INJURY OR HARM WAS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573397 ↗
• MalfunctionJan 24, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  PER CUSTOMER COMPLAINT, THE MONITRON DISPLAY WAS IN USE WITH A VDR VENTILATOR AND THE SCREEN FROZE. THIS MALFUNCTION TOOK PLACE WHILE IN USE ON A PATIENT. NO PATIENT HARM OR INJURY REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573359 ↗
• MalfunctionJan 24, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  PER CUSTOMER COMPLAINT, WHILE DEVICE WAS IN USE ON A PATIENT, THE MONITOR SCREEN FROZE. NO PATIENT INTERVENTION WAS REQUIRED, OTHER THAN SUCTIONING. THE MONITOR RESUMED FUNCTIONING AND UNFROZE AFTER THE RESPIRATORY THERAPIST PRESSED DISPLAY MODE AND SCALE BUTTONS. NO PATIENT INJURY OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573350 ↗

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)