Babylog VN600 8422200Recalls & reported problems
Drägerwerk AG & Co. KGaA · Class 2
Quick summary
This Dräger Babylog VN600 ventilator is a continuous ventilator for facility use. Reports mostly describe touchscreen displays not working, making the device hard to program, with some mentions of failure to deliver air and unexpected shutdowns. There are 23 reports that mention no deaths and 1 injury. No recalls name this device, with reports rising to 15 in the last 12 months from 5 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04048675551713), received between Dec 21, 2023 and Jun 30, 2026 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (14 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.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Program or Calibrate14
- Failure to Deliver6
- No Display/Image4
- Unexpected Shutdown3
- Complete Loss of Power2
- Failure to Read Input Signal2
- Gas Output Problem2
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Increased Respiratory Rate1
- Low Oxygen Saturation1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCHSCREEN OF THE DEVICE WAS MALFUNCTIONING. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25663735 ↗MalfunctionJun 30, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCHSCREEN OF THE DEVICE WAS MALFUNCTIONING. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25663734 ↗MalfunctionJun 30, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCHSCREEN OF THE DEVICE WAS MALFUNCTIONING. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25663732 ↗MalfunctionMay 12, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150808 ↗MalfunctionMay 12, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150747 ↗MalfunctionMay 12, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150743 ↗MalfunctionMay 12, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150742 ↗MalfunctionMay 12, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150741 ↗MalfunctionMay 11, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135042 ↗MalfunctionMay 11, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134647 ↗MalfunctionMay 11, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134646 ↗MalfunctionMay 11, 2026Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE TOUCH SCREEN OF THE DEVICE WAS NOT FUNCTIONING DURING USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134643 ↗MalfunctionApr 20, 2026No Display/Image; Failure to Read Input Signal
IT WAS REPORTED THAT THE DISPLAY OF THE DEVICE SHUT DOWN DURING OPERATION. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24923796 ↗MalfunctionJan 26, 2026Decrease in Pressure; Failure to Deliver; Imprecise or Erratic Results
IT WAS REPORTED THAT THE DEVICE ISSUED THE ALARM MESSAGE "DEVICE FAILURE 1" AND PERFORMED A REBOOT DURING PATIENT USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176276 ↗MalfunctionNov 26, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT A 'DEVICE ERROR 14' OCCURRED ON (B)(6) 2025. ON (B)(6) 2025, A 'DEVICE FAILURE 14' WAS POSTED AGAIN. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655514 ↗MalfunctionJul 3, 2025Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown
IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING USE WITH A PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22392466 ↗MalfunctionJun 5, 2025Failure to Read Input Signal; Failure to Deliver; Activation Failure; Failure to Read Input Signal; Failure to Deliver; Activation Failure
THE FOLLOWING ISSUE WAS REPORTED: PROBLEM OF "DEVICE FAILURE 02" ARISES WHILE CONTINUE RUNNING OF VENTILATOR MORE THAN TWO DAYS. BEFORE AND AFTER OF THIS ERROR, SYSTEM TEST IS SUCCESSFUL ALWAYS. ONCE WE RESTART THE VENTILATOR, NO DEVICE FAILURE IS THERE BUT COMES AGAIN WITHIN 2- OR 3-DAYS CONTINUOUS VENTILATION. WE HAVE OBSERVED THIS DEVICE FAILURE 3 TIMES. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22148709 ↗MalfunctionMay 8, 2025No Display/Image; Human-Device Interface Problem; Unexpected Shutdown; No Display/Image; Human-Device Interface Problem; Unexpected Shutdown
IT WAS REPORTED THAT THE DEVICE TURNED OFF WHILE CONNECTED TO A PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21983398 ↗MalfunctionMar 7, 2025Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown
IT WAS REPORTED THAT THE DEVICE SUDDENLY SHUT DOWN DURING USE ON A PATIENT. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21544696 ↗MalfunctionNov 11, 2024Gas Output Problem; Failure to Deliver; Intermittent Communication Failure; Gas Output Problem; Failure to Deliver; Intermittent Communication Failure
THE FOLLOWING ISSUE WAS REPORTED: THE CUSTOMER REPORTED AN ISSUE WHERE THE DEVICE SUDDENLY SHUT DOWN DURING OPERATION WHILE CONNECTED TO A PATIENT. THE DEVICE ALARMED. ACCORDING TO THE INITIAL LOG ANALYSIS, THE DEVICE HAD STOPPED UNEXPECTEDLY AT THE REPORTED TIME. NO PAT. HEALTH CONSEQUENCES HAVE BEEN REPORTED. HOWEVER, IN CASE THE BREATHING PRESSURE (INCL. PEEP) DROPS TO AMBIENT, A DETERIORATION IN STATE OF HEALTH CANNOT BE EXCLUDED FOR PATIENTS WITH DIFFICULT LUNG/VENTILATION CONDITIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20650788 ↗MalfunctionAug 12, 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" AND ¿ALARM SYSTEM ERROR¿. THE SCREEN OF THE DEVICE BLACKED OUT. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19961574 ↗InjuryMay 16, 2024Complete Blockage; Gas Output Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Complete Blockage; Gas Output Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRETERM, SEDATED BABY WAS CONNECTED TO THE VENTILATOR. AT AROUND 03:30 P.M. THE "BABY SUDDENLY DETERIORATED WITH POOR PERFUSION AND DESATURATION. BABY WAS CHECKED AND A CHEST X-RAY WAS DONE, BUT NO PNEUMOTHORAX WAS NOTED. THE VENTILATOR WAS SHOWING A HIGH RESPIRATORY RATE (UP TO 114) AND A PRESSURE AND FLOW RATE CURVE WITH MARKEDLY CHANGED TO FASCICULATION. THE BABY WAS DISCONNECTED FROM THE VENTILATOR AND THE TEST LUNG WAS CONNECTED. THE SAME PROBLEM CONTINUED EVENT WITH THE TEST LUNG.".
Patient problems: Increased Respiratory Rate; Low Oxygen Saturation
MAUDE report 19330508 ↗MalfunctionDec 21, 2023Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18370903 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.