IACS Workstation Neonatal Care 8417400Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 04048675250418), received between Apr 28, 2017 and Mar 26, 2026 — classified as 6 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (18 reports).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K093632); 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. Feb 14, 2022Class IITerminated

   Cybersecurity Improvement Action-not equipped against potential cyber security threats

   Z-0871-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Communication or Transmission Problem

  THE FOLLOWING WAS REPORTED TO DRAEGER: DURING USE, DEVICE FAILURE ALARM AND STOPPED VENTILATING. DEVICE ALARMED. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697517 ↗
• InjuryMar 24, 2026Use of Device Problem; Pressure Problem; No Apparent Adverse Event

  IT WAS REPORTED TO DRÄGER THAT THE VENTILATOR SUDDENLY POSTED ALARMS DURING USE INDICATING A DISTURBED VENTILATION. AS PER REPORT, THE USERS OBSERVED A SMALL AMOUNT OF BLOOD IN THE ET TUBE, AND THE PATIENT EXPERIENCED A DESATURATION. THE REPORT DOES NOT CONTAIN A CLEAR INDICATION FOR THE POTENTIAL PRESENCE OF A DEVICE MALFUNCTION, AND THE USER DID NOT ALLEGE ONE.

  Patient problems: Low Oxygen Saturation; Upper Respiratory Tract Injury

  MAUDE report 24673137 ↗
• MalfunctionFeb 13, 2026No Display/Image; Failure to Read Input Signal; Unexpected Shutdown

  IT WAS REPORTED BY THE USER: PATIENT WAS BEING TRANSFERRED ONTO DEVICE WHEN IT SWITCHED OFF. BATTERY FULLY CHARGED AND PLUGGED INTO MAINS AT THE TIME. REPLACEMENT DEVICE FOUND. MACHINE WAS THEN SWITCHED BACK ON, THE VENTILATION WORKED BUT THE SCREEN WAS BLANK. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331164 ↗
• MalfunctionFeb 11, 2026No Display/Image; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DISPLAY OF THE DEVICE WENT BLANK. REPORTEDLY, THE VENTILATION WAS NOT INTERRUPTED. THE DEVICE WAS REPLACED. NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312661 ↗
• MalfunctionFeb 4, 2026No Display/Image; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DISPLAY OF THE DEVICE TURNED OFF DURING USE. IT WAS NOT REBOOTING. REPORTEDLY, THE VENTILATION WAS NOT INTERRUPTED. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256402 ↗
• MalfunctionNov 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR IN WHICH THE FOLLOWING WAS STATED: "DURING NORMAL OPERATION OF THE VENTILATOR IN THE ANESTHESIOLOGY DEPARTMENT, THE DEVICE SUDDENLY ALARMED AND BECAME INOPERABLE. A BACKUP DEVICE WAS DEPLOYED AS REPLACEMENT." THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT THE EVENT MAY HAVE LED TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603251 ↗
• MalfunctionNov 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED IN A USER FACILITY REPORT TO NATIONAL AUTHORITY THAT DURING USE ON A PATIENT THE MONITOR FOR PULSE OXIMETRY ALARMED AND A CHANGED SKIN COLOR WAS NOTICED BUT THE VENTILATOR FAILED TO TRIGGER A CORRESPONDING ALARM.

  Patient problems: Insufficient Information

  MAUDE report 23597866 ↗
• MalfunctionOct 28, 2025Decrease in Pressure; Inaccurate Delivery; Gas/Air Leak; Improper Flow or Infusion; Decrease in Pressure; Inaccurate Delivery; Gas/Air Leak; Improper Flow or Infusion

  IT WAS REPORTED FROM THE CUSTOMER THAT THE VN500 DEVICE ALARMED WITH 'AIRWAY PRESSURE LOW' WHILST IN USE ON A PATIENT. PATIENT SUFFERED REPEATED INSTANCES OF DESATURATION. THE DEVICE WAS EXCHANGED. AT THE PRESENT TIME, A RESTRICTION OR A STOPP OF VENTILATION CANNOT BE EXCLUDED. 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: Low Oxygen Saturation

  MAUDE report 23401431 ↗
• MalfunctionOct 15, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE SCREEN OF THE DEVICE TURNED RED AND THEN TURNED OFF. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300844 ↗
• MalfunctionOct 15, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING USE, THE COCKPIT WENT BLANK AND REBOOTED. THERE WAS NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289760 ↗
• MalfunctionSep 9, 2025No Display/Image; Failure to Read Input Signal; No Display/Image; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DISPLAY OF THE DEVICE BLANKED OUT. IT STATED REBOOTING AND ASKED TO INSERT A BOOTABLE MEDIUM. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003661 ↗
• MalfunctionAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR WITH THE FOLLOWING STATEMENT: "ON (B)(6) 2025, THE RESPONSIBLE NURSE OBSERVED THE PATIENT'S OXYGEN SATURATION AT 85%. UPON IMMEDIATE INSPECTION, IT WAS DISCOVERED THAT THE RESPIRATORY THERAPY SYSTEM, WHICH HAD BEEN IN USE FOR 12 HOURS, HAD AUTOMATICALLY SHUT DOWN, WITH THE POWER SWITCH IN THE OFF POSITION. AFTER RESETTING THE POWER SWITCH, THE VENTILATOR BACKED TO NORMAL USE, AND THE CHILD'S OXYGEN SATURATION SUBSEQUENTLY INCREASED TO 96%. " NO HEALTH CONSEQUENCES FOR THE PATIENT HAVE RESULTED FROM THE EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22892375 ↗
• MalfunctionAug 14, 2025No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT WHILE ON A PATIENT THE DISPLAY TURNED RED, THEN SHUTDOWN. THE VENTILATOR IS REPORTED TO HAVE KEPT WORKING. THERE WAS NOT REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802165 ↗
• MalfunctionJul 21, 2025Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure; Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE DEVICE RESTARTED AND GENERATED A PIEZO ALARM. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554483 ↗
• MalfunctionJun 10, 2025No Display/Image; Failure to Read Input Signal; No Display/Image; Failure to Read Input Signal

  IT WAS REPORTED THAT THE SCREEN OF THE DEVICE TURNED BLANK. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175544 ↗
• MalfunctionMay 15, 2025No Display/Image; Decrease in Pressure; Failure to Read Input Signal; No Display/Image; Decrease in Pressure; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DEVICE PERFORMED A RESTART DURING USE ON A PATIENT ON (B)(6) 2025. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED. THE AFFECTED DEVICE WAS REMOVED FROM PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026004 ↗
• MalfunctionMar 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE COCKPIT OF THE DEVICE WENT DARK DURING USE. EVENTUALLY, THE COCKPIT REBOOTED. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675647 ↗
• MalfunctionMar 11, 2025Complete Blockage; Gas Output Problem; Adverse Event Without Identified Device or Use Problem; Complete Blockage; Gas Output Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEVICE FAILURE OCCURRED DURING USE. THIS SITUATION WAS ALARMED BY THE DEVICE. IT WAS FURTHER REPORTED THAT A CIRCUIT DISCONNECTION FREQUENTLY OCCURRED PRIOR TO THE DEVICE FAILURE. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570593 ↗
• InjuryJan 17, 2025Gas Output Problem; Failure to Deliver; Improper Flow or Infusion; Physical Resistance/Sticking; Gas Output Problem; Failure to Deliver; Improper Flow or Infusion; Physical Resistance/Sticking

  IT WAS REOPORTED THAT THE VN500 WAS IN USE ON AN INTUBATED NEONATE PATIENT IN THE NICU AT SICKKIDS HOSPITAL. THE BABY HAD BEEN RECENTLY ADMITTED ONTO THE UNIT. THE DEVICE HAD HAD A SYSTEM AND BREATHING CIRCUIT CHECK DONE. THE BABY WAS BEING VENTILATED ON HFO+VG. VENTILATION PARAMETERS UNKNOWN AT THIS TIME. A CODE BLUE WAS CALLED, UPON THE RESPIRATORY THERAPIST'S ARRIVAL, IT WAS REPORTED BY THE BEDSIDE RN THAT THE PATIENT WAS HAVING AN ACUTE CARDIORESPIRATORY DECOMPENSATION IN THE FORM OF A PROFOUND BRADYCARDIA AND DESATURATION. WHEN THE NURSE ARRIVED AT THE PATIENT'S BEDSIDE, THE BABY WAS STILL CONNECTED TO THE VENTILATOR VIA ETT AND THERE WERE NO AUDIBLE OR VISUAL ALARMS DISPLAYED ON THE VENTILATOR. UPON FURTHER INSPECTION, THE BEDSIDE NURSE REALIZED THAT THE NORMAL OSCILLATION WAVEFORM ON THE VENTILATOR SCREEN WAS NOT HAPPENING, AND THE BABY HAD NO CHEST SHAKE LIKE NORMALLY ON HFO, AND THE NORMAL HFO SOUNDS WERE NOT HEARD FROM THE VENTILATOR. THE NURSE TOOK THE BABY OFF THE VENTILATOR AND STARTED MANUAL POSITIVE PRESSURE VENTILATION VIA FLOW-INFLATING BAG. WHEN THE RESPIRATORY THERAPISTS ARRIVED AT THE BEDSIDE AFTER THE CODE-BLUE WAS CALLED, THE PATIENT HAD RECOVERED FROM THE BRA

  Patient problems: Bradycardia

  MAUDE report 21176435 ↗
• MalfunctionDec 18, 2024Complete Blockage; Gas Output Problem; Failure to Deliver; Adverse Event Without Identified Device or Use Problem; Complete Blockage; Gas Output Problem; Failure to Deliver; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE FAILED WHILE BEING USED ON A PATIENT. AN ERROR MESSAGES WAS DISPLAY ON THE SCREEN. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20961881 ↗
• MalfunctionNov 28, 2024No Display/Image; Failure to Read Input Signal; No Display/Image; Failure to Read Input Signal

  IT WAS REPORTED THAT THE SCREEN OF THE DEVICE WENT BLANK DURING USE. REPORTEDLY, THE VENTILATION WAS NOT AFFECTED AND CONTINUED AS SET. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804584 ↗
• MalfunctionNov 11, 2024Complete Blockage; Gas Output Problem; Adverse Event Without Identified Device or Use Problem; Complete Blockage; Gas Output Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: ¿THE DEVICE WAS BEING USED WITH HFO. SINCE AROUND 00:30, WATER WAS ACCUMULATED IN THE CORRUGATED TUBE, SO THE CORRUGATED TUBE WAS REMOVED, AND THE WATER WAS DUMPED. THEN THE CORRUGATED TUBE WAS ATTACHED BUT THE VENTILATION DID NOT WORK WELL, AND IT BEGAN TO HAVE ERROR. HOSPITAL ME WAS CALLED AND THEY WERE DEALING WITH IT, BUT IT WASN'T STABLE. AROUND 01:30 INSPIRATORY WAS NO LONGER PERFORMED. THE DEVICE WAS REPLACED.¿ THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650793 ↗
• MalfunctionOct 15, 2024Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power; Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power

  IT WAS REPORTED THAT THE HOSPITAL EXPERIENCED A SUDDEN POWER OUTAGE, ACTIVATING THE VENTILATOR'S BATTERY. THE VENTILATOR ALARMED ALMOST IMMEDIATELY FOR LOW BATTERY AND SHUT DOWN SHORTLY AFTER. THE NURSE PROMPTLY ASSISTED THE PATIENT WITH AN AMBU BAG. POWER WAS RESTORED 28 MINUTES LATER, AND THE VENTILATOR OPERATED NORMALLY AFTERWARDS. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449707 ↗
• MalfunctionOct 15, 2024No Display/Image; Failure to Read Input Signal; No Display/Image; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DISPLAY OF THE DEVICE WENT BLANK WHILE IN USE ON A PATIENT. REPORTEDLY, THE VENTILATION CONTINUED AS SET. THE VENTILATOR WAS REPLACED. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449706 ↗
• MalfunctionSep 16, 2024Restricted Flow rate; Inaccurate Flow Rate; Medical Gas Supply Problem; Output Problem; Restricted Flow rate; Inaccurate Flow Rate; Medical Gas Supply Problem; Output Problem

  IT WAS REPORTED THAT DURING OPERATION IN SIMV, SUDDENLY APNEA ALARM RANG AND VENTILATION "0" WAS DISPLAYED ON THE SCREEN. AFTER REPLACING THE DEVICE, PERFORMED SYSTEM CHECK. PRESSURE SENSOR VALVE, EXPIRATORY VALVE, AND SAFETY VALVE WERE INDICATING ERRORS. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20222712 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093632. One submission often covers many models, so check the product and lot details in each record.

• Z-0109-2022 · Sep 10, 2021 · Open, Classified
  Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients
• Z-0827-2016 · Feb 4, 2016 · Terminated
  Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
• Z-0436-2016 · Dec 1, 2015 · Terminated
  Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pedia
• Z-2343-2015 · Jul 13, 2015 · Terminated
  PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
• Z-1298-2014 · Feb 7, 2014 · Terminated
  Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during shor