Babylog VN800 8422400Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04048675542476), received between Sep 28, 2022 and Mar 5, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (11 reports).

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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Complete Blockage; Gas Output Problem; Failure to Deliver; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE STOPPED WORKING WHILE THE PATIENT WAS BEING HANDLED FOR EXAMINATION AND CANNULATION. THE CPAP MASK WAS DISCONNECTED FOR A FEW MINUTES. UPON RECONNECTION, IT WAS NOTED THAT THE DEVICE WAS NOT DELIVERING ANY AIRWAY PRESSURE. THE MONITOR REMAINED FUNCTIONAL AND CONFIRMED THE SAME. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516669 ↗
• MalfunctionFeb 19, 2026Gas Output Problem; Failure to Deliver; Complete Loss of Power; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING USE, A SUDDEN BEEPING ALARM SOUNDED, THE POWER SHUT DOWN, THE SCREEN WENT BLACK, AND VENTILATION STOPPED. AFTER THAT, TURNING THE POWER OFF AND ON ONLY TRIGGERED THE ALARM SOUND, AND THE UNIT DID NOT START. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385613 ↗
• MalfunctionFeb 12, 2026No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT DURING TURNING THE MONITOR TO ONE SIDE IT GOES BLANK AND WHEN TURN IT TO THE OTHER THE SIDE IT WILL COME BACK ON. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320449 ↗
• MalfunctionJan 16, 2026Display or Visual Feedback Problem; Image Display Error/Artifact; Device Difficult to Program or Calibrate

  THE FOLLOWING WAS REPORTED: SCREEN WENT BLANK - CAME BACK UP - THEN TOUCH SCREEN FROZE UP DATE/TIME: (B)(6) 2025/TIME UNKNOWN DURING THE NIGHT. SWAPPED VENT TO RESOLVE. NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091610 ↗
• MalfunctionDec 18, 2025Failure to Deliver; Device Sensing Problem; No Visual Prompts/Feedback; Failure to Deliver; Device Sensing Problem; No Visual Prompts/Feedback

  IT WAS REPORTED THAT THE DEVICE STOPPED DELIVERING BREATHS WHILST IN USE ON A PATIENT. THE USER INTERFACE WENT BLANK AT THE SAME TIME. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840872 ↗
• MalfunctionDec 15, 2025Device Difficult to Program or Calibrate; Human-Device Interface Problem; Output Problem; Device Difficult to Program or Calibrate; Human-Device Interface Problem; Output Problem

  IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE STOPPED WORKING DURING USE ON A PATIENT. THE DISPLAY LOCKED AND NO CHANGES COULD BE MADE. REPORTEDLY, THE DEVICE KEPT VENTILATING THE PATIENT. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801257 ↗
• MalfunctionDec 1, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT CUSTOMER STATES UNIT SHUT OFF WITH HIGH PITCHED ALARM WHILE ON A PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678879 ↗
• MalfunctionOct 28, 2025Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE SCREEN OF THE DEVICE WENT BLACK, AND THE VENTILATION STOPPED DURING USE. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23406225 ↗
• MalfunctionJul 29, 2025No Display/Image; Device Difficult to Program or Calibrate; Unexpected Shutdown; No Display/Image; Device Difficult to Program or Calibrate; Unexpected Shutdown

  IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN DURING USE AND COULD NOT BE RESTARTED. IT WAS REPORTED THAT NO PATIENT INJURY OCCURRED. AT THE TIME OF THE INCIDENT, THE DEVICE WAS CONNECTED TO THE MAINS POWER AND THE BATTERY WAS CHARGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641058 ↗
• MalfunctionJun 25, 2025Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure; Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE UNIT SHUT OFF WHILE IN USE. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326779 ↗
• MalfunctionApr 24, 2025Degraded; Device Difficult to Program or Calibrate; Human-Device Interface Problem; Output Problem; Degraded; Device Difficult to Program or Calibrate; Human-Device Interface Problem; Output Problem

  IT WAS REPORTED THAT THE TOUCH PANEL DOES NOT WORK AND CANNOT BE OPERATED AT ALL. TURNING OFF WAS ATTEMPTED BUT FAILED. THERE WAS NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21897985 ↗
• InjuryMar 26, 2025Use of Device Problem; No Apparent Adverse Event; Device Handling Problem; Misassembled During Installation; Use of Device Problem; No Apparent Adverse Event; Device Handling Problem; Misassembled During Installation

  IT WAS REPORTED FROM CUSTOMER THAT DUE TO THE DESIGN OF THE VENTILATOR IT IS POSSIBLE TO INSERT THE INSPIRATORY TUBING INTO THE EXPIRATORY PORT AND VICE VERSA BETWEEN THE HUMIDITY AND VENTILATOR, AS THE TUBING AND PORTS ARE THE SAME SIZE, MAKING IT AN INHERENTLY UNSAFE DESIGN AND AT RISK OF FUTURE INCIDENTS. THIS OCCURRED ON A DRAGER BABYLOG VN800 VENTILATOR IN USE ON A BABY BETWEEN (B)(6) 2024, RESULTING IN NO HUMIDIFIED GASES GOING TO THE BABY DURING THIS TIME. IN THIS CASE IT LED TO RESPIRATORY SECRETIONS DRYING OUT AND BLOCKING THE ET TUBES, NEEDING X5 ET TUBE REPLACEMENTS IN 11 DAY PERIOD DUE TO OBSTRUCTION WITH THESE THICK SECRETIONS, AS WELL AS REGULAR ET LAVAGE TO REMOVE SECRETIONS. THE BABY POSSIBLY STAYED ON VENTILATOR LONGER AND HAD INCREASED HOSPITAL STAY FOR MORE DAYS THAN WOULD HAVE BEEN. TO CLEAR SECRETIONS REQUIRES HUMIDITY AND THE CILIA HAIRS IN THE LINING OF THE AIRWAY MOVES THESE UPWARDS TO BE CLEARED. THE DRY GASES MAY HAVE AFFECTED THESE CILIA, MAKING IT MORE DIFFICULT FOR SECRETIONS TO BE CLEARED AND MAY HAVE CAUSED LONG TERM DAMAGE. BABY IS NOW IN AIR AND HAS NO INCREASED WORK OF BREATHING OR COUGH AND IT IS THEREFORE UNLIKELY THAT THE LACK OF HUMIDITY HAS HA

  Patient problems: Respiratory Distress Syndrome of Newborns

  MAUDE report 21695998 ↗
• MalfunctionDec 18, 2024Decrease in Pressure; Failure to Deliver; Imprecise or Erratic Results; Decrease in Pressure; Failure to Deliver; Imprecise or Erratic Results

  IT WAS REPORTED THAT THE DEVICE ISSUED A DEVICE FAILURE ALARM DURING USE. THE DEVICE SHUT DOWN. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20966547 ↗
• MalfunctionDec 16, 2024Decrease in Pressure; Failure to Deliver; Imprecise or Erratic Results; Decrease in Pressure; Failure to Deliver; Imprecise or Erratic Results

  IT WAS REPORTED THAT THE DEVICE DISPLAYED A DEVICE FAILURE DURING PATIENT USE. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20936226 ↗
• MalfunctionOct 15, 2024Human-Device Interface Problem; Output Problem; Human-Device Interface Problem; Output Problem

  IT WAS REPORTED THAT THE TOUCH SCREEN WAS NOT WORKING. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449710 ↗
• MalfunctionSep 30, 2024Decrease in Pressure; Failure to Deliver; Imprecise or Erratic Results; Decrease in Pressure; Failure to Deliver; Imprecise or Erratic Results

  THE FOLLOWING WAS REPORTED: VENT FAIL WHILE IN USE - NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331745 ↗
• MalfunctionSep 9, 2024Device Difficult to Program or Calibrate; Human-Device Interface Problem; Output Problem; Device Difficult to Program or Calibrate; Human-Device Interface Problem; Output Problem

  IT WAS REPORTED THAT THE CONTROL PANEL WAS GLITCHING AND FREEZING UP. THE CONTROL PANEL WAS UNRESPONSIVE. THE DEVICE WOULD NOT SHUT DOWN AND THE USER HAD TO USE THE ROCKER SWITCH. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168825 ↗
• MalfunctionJun 26, 2024Loss of Data; No Apparent Adverse Event; Unexpected Shutdown; Loss of Data; No Apparent Adverse Event; Unexpected Shutdown

  IT WAS REPORTED THAT MACHINE HAD DATA LOSS MESSAGE AND THEN SHUT DOWN WHILE IN USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612415 ↗
• MalfunctionMay 15, 2024Failure to Deliver; Output Problem; Failure to Deliver; Output Problem

  IT WAS REPORTED THAT THE DEVICE SHUTDOWN INTERMITTENTLY. NO INJURY REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318472 ↗
• MalfunctionMay 8, 2024No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE DEVICE DISPLAYED THE ALARM MESSAGE "DEVICE FAILURE 14". NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266390 ↗
• MalfunctionMay 7, 2024No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE DEVICE DISPLAYED THE ALARM MESSAGE "DEVICE FAILURE 14". NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257974 ↗
• MalfunctionSep 28, 2022Gas Output Problem; Device Difficult to Program or Calibrate; Failure to Deliver; Gas Output Problem; Device Difficult to Program or Calibrate; Failure to Deliver

  IT WAS REPORTED THAT THE SCREEN WENT BLANK, AND THE DEVICE STOPPED VENTILATING DURING USE ON PATIENT, THE DEVICE WAS IMMEDIATELY SWAPPED, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500607 ↗