Oxylog 3000plus 5704833Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 04048675249214), received between Nov 1, 2017 and Jun 17, 2026 — classified as 4 deaths, 6 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (32 reports).

4 other recalls cover devices cleared under the same FDA submission (K103625); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PATIENT TRANSFER, THE TRANSPORT VENTILATOR DISPLAYED A DEVICE MALFUNCTION AND BECAME INOPERABLE. NO INJURY OR HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530250 ↗
• DeathJun 4, 2026Medical Gas Supply Problem

  IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO THE DEVICE COUPLED TO AN O2 CYLINDER WITH DIGITAL DISPLAY. THE DIGITAL DISPLAY OF THE O2 CYLINDER WAS FOUND TO BE OFF AND THE O2 CYLINDER WAS EXCHANGED. AFTER A FEW MINUTES THE PATIENT WAS IDENTIFIED AS HAVING BRADYCARDIA AND LOW OXYGEN SATURATION. IT WAS FOUND THAT THE EXCHANGED O2 CYLINDER WAS EMPTY. THE PREVIOUS O2 CYLINDER WAS CONNECTED AND WAS FUNCTIONING NORMALLY. THE PATIENT REQUIRED CPR AND PASSED AWAY.

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 25388392 ↗
• MalfunctionMay 19, 2026Improper Flow or Infusion

  THE FOLLOWING WAS REPORTED: A PAEDIATRIC CARDIAC ARREST PATIENT, 7-YEAR-OLD MALE FOLLOWING HYPOXIC INJURY (CHOKING). PHEA CCP, POST PHEA, THE VENTILATOR WAS CONNECTED (150MLS/ RR 24BPM/ FIO2 100%) AND HAD POOR ETCO2- INEFFECTIVE. NOTICEABLY LESS CHEST EXPANSION. REVERTED TO BVM. MUCH IMPROVED. NOTED ETCO2 LOOSE IN MONITOR- CORRECTED. TRIED OXYLOG AGAIN- BUT ABANDONED AS SAME ISSUE. HAND VENTILATED WITH BVM TO HOSPITAL. NO SERIOUS INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216229 ↗
• MalfunctionMay 11, 2026No Device Output; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CRITICALLY ILL PATIENTS RESPIRATORY CONDITION HAD DETERIORATED. MANUAL VENTILATION AND LATER THE INTUBATION IMPROVED THE SPO2 AND ETCO2 LEVELS. DURING THE FOLLOWING OXYLOG VENTILATION, NO RISE AND FALL OF CHEST SEEN AND NO AIR ENTRY TO EITHER LUNG ON AUSCULTATION. THEREFORE MANUAL VENTILATION WAS THEN CONTINUED UNTIL THE PARAMEDIC ARRIVED. MANUALLY VENTILATED 3HRS. NO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134652 ↗
• MalfunctionFeb 27, 2026Accessory Incompatible; Fire; Unexpected Therapeutic Results

  IT WAS REPORTED THAT: ¿THE OXYLOG WAS HOOKED AT THE REAR SIDE RAIL OF THE TRANSPORT BED DURING PATIENT TRANSPORTATION FROM ICU TO TAC. DURING THE MOVEMENT OF THE PATIENT BETWEEN THE BED AND THE TAC TABLE THE USER NOTED THE OXYGEN HOSE DISCONNECTION FROM THE DEVICE WITH A LITTLE EXPLOSION, SPARKS AND FLAMES. THE USER QUICKLY CLOSED THE OXYGEN CYLINDER VALVE AND EXTINGUISHED THE FIRE. THE DEVICE SHOWED AN ALARM BUT WAS NOT POSSIBLE FOR THE USER TO IDENTIFY WHICH ONE. NOBODY WAS INJURED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468058 ↗
• MalfunctionFeb 25, 2026Use of Device Problem; Failure to Deliver; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS IN USE ON A PATIENT WHEN IT STOPPED WORKING AND ALARMED WITH 'TECHNICAL FAILURE'. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24440489 ↗
• MalfunctionFeb 11, 2026Failure to Charge; Output Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED A BATTERY ISSUE AND THE VENTILATOR STOPPED WHILST IN USE. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

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

  MAUDE report 24312659 ↗
• MalfunctionJan 19, 2026Fire; Overheating of Device

  IT WAS REPORTED THAT A SPARK OCCURRED ON THE OXYLOG 3000+, SN: (B)(6). THE DEVICE (OXYLOG 3000+ AND ALDUK4) HAS BEEN SENT TO THE CENTRAL WORKSHOP IN LÜBECK FOR FURTHER INSPECTION. USERS AT THE EMERGENCY DEPARTMENT REPORTED THAT THE SPARKING OCCURRED DURING A CYLINDER REPLACEMENT. THE CUSTOMER ALREADY HAS A REPLACEMENT DEVICE. THERE WAS NO FIRE AND NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109023 ↗
• MalfunctionJan 14, 2026Gas Output Problem; Decrease in Pressure; Reset Problem; Unexpected Shutdown

  IT WAS REPORTED VENTILATOR POWERED DOWN DURING TRANSPORT. THE USER OBSERVED NO ERROR CODE AND ONLY SAW A BLACK SCREEN. THE ISSUE OCCURRED WHEN THE PATIENT WAS TRANSFERRING ONTO THE VENTILATOR IN THE INTENSIVE CARE UNIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065393 ↗
• InjuryOct 9, 2025Use of Device Problem; Failure to Deliver; Use of Device Problem; Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION. THE HEARTBEAT WAS RESTORED, AND THE PATIENT WAS CONNECTED TO THE OXYLOG 3000PLUS FOR CONTROLLED VENTILATION. SHORTLY, AFTER THE DEVICE ISSUED AN ALARM TO RESELECT THE CIRCUIT. UPON INSPECTION, THE CIRCUIT CONNECTION WAS FOUND TO BE CORRECT. SUBSEQUENTLY, THE DEVICE ALARMED FOR DEVICE MALFUNCTION AND CEASED OPERATION. THE VENTILATOR STILL DID NOT FUNCTION AFTER RESTARTING. THIS CAUSED THE PATIENT'S HEART RATE TO DROP AGAIN, NECESSITATING CONTINUED EXTERNAL CHEST COMPRESSIONS, MANUAL VENTILATION WITH A SIMPLE BREATHING AIRBAG, AND EPINEPHRINE FOR CARDIAC STIMULATION. AFTER ACTIVE RESUSCITATION, THE PATIENT REGAINED HEARTBEAT.

  Patient problems: Cardiac Arrest

  MAUDE report 23252772 ↗
• MalfunctionJul 24, 2025Failure to Charge; Failure to Run on Battery; No Apparent Adverse Event; Failure to Charge; Failure to Run on Battery; No Apparent Adverse Event

  IT WAS REPORTED THAT AS THE BATTERY CAPACITY STARTED TO DECREASE DURING USE ON A PATIENT THE USER STARTED CHARGING THE BATTERY. THEN THE DEVICE ALARMED INT. BATTERY CHARGING INOP. THE USER DETACHED AND ATTACHED THE BATTERY WHICH RESULTED IN A DEVICE SWITCHING OFF WHILE THE BATTERY WAS DETACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584938 ↗
• MalfunctionJul 22, 2025Premature 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 DEVICE FAILED WHILST VENTILATING A PATIENT. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564362 ↗
• MalfunctionJul 17, 2025Gas Output Problem; Failure to Sense; Failure to Deliver; Gas Output Problem; Failure to Sense; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE STOPPED VENTILATION AND SHOWED A TECHNICAL FAULT DURING USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528548 ↗
• MalfunctionJun 3, 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 THE PATIENT WAS BEING TRANSFERRED BETWEEN TWO AREAS, WHEN THE STAFF NOTICED THAT THE PATIENT WAS NO LONGER VENTILATING-END TIDAL CO2 WAS NOT BEING RECORDED. THE STAFF, AS A RESULT MANUALLY VENTILATED THE PATIENT UNTIL THE END TIDAL CO2 REAPPEARED-WHICH WAS STRAIGHTFORWARD. THEY REBOOTED THE VENTILATOR AND PUT THE PATIENT BACK ON IT AND SUCCESSFULLY TRANSFERRED THE PATIENT. THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131448 ↗
• MalfunctionMay 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN EXTERNAL EXAMINATION ON A PATIENT THE DEVICE ALARMED INDICATING "!!! DEVICE MALFUNCTION", AND IT STOPPED WORKING IMMEDIATELY UPON ALARM. NO INJURY OR HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034210 ↗
• InjuryMay 5, 2025Use of Device Problem; Failure to Deliver; Use of Device Problem; Failure to Deliver

  IT WAS REPORTED THAT DURING THE PLACEMENT OF A CENTRAL VENOUS CATHETER, IT WAS NOTED THAT THE PATIENT WAS NOT BEING VENTILATED THROUGH THE DEVICE. THERE WAS NO CHEST MOVEMENT OF THE PATIENT. THERE WAS NO ALARM FROM THE DEVICE. THE PATIENT THEN BECAME BRADYCARDIC AND REQUIRED RESUSCITATION AND HAD TO BE VENTILATED MANUALLY. AFTER SUCCESSFUL RESUSCITATION, THE DEVICE WAS PUT BACK INTO OPERATION AND SHOWED NO ABNORMALITIES.

  Patient problems: Bradycardia

  MAUDE report 21958704 ↗
• MalfunctionMar 24, 2025Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT AROUND 10:34 AFTER INTERNAL BATTERY DISCHARGING MESSAGE OCCURRED, IT PERFORMED SHUTDOWN. THE DEVICE WAS REPLACED WITH SUBSTITUTE DEVICE. NO PAT. HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676035 ↗
• InjuryMar 20, 2025Use of Device Problem; Failure to Deliver; Use of Device Problem; Failure to Deliver

  IT WAS REPORTED IN THE USER FACILITY REPORT THAT A TRAUMA PATIENT CAME TO THE EMERGENCY ROOM IN POOR CONDITION. THE PATIENT HAD TO BE URGENTLY INTUBATED. BLOOD PRESSURE WAS GOOD. THE AIRWAY WAS SECURED WITHOUT ANY PROBLEMS. THE PATIENT WAS IMMEDIATELY CONNECTED TO THE OXYLOG 3000 VENTILATOR. THE MACHINE HAD BEEN ASSEMBLED IN THE EMERGENCY ROOM. THE VENTILATOR WAS SWITCHED ON, NO INFORMATION WAS DISPLAYED ON THE MACHINE'S SCREEN, NO CURVES, NO VOLUMES. HOWEVER, YOU CAN HEAR HOW THE MACHINE IS PUSHING AIR IN AT THE SPECIFIED FREQUENCY. SOON THE MACHINE GIVES AN ALARM OF APPARENTLY HIGH PRESSURE. AT FIRST, IT SEEMS THAT THE PATIENT IS VENTILATED NORMALLY. HOWEVER, THE PATIENT'S BLOOD PRESSURE QUICKLY COLLAPSES. IT IS NOTICED THAT THE VENTILATOR IS NOT REALLY WORKING NORMALLY, AIR IS GOING IN, BUT NOT OUT. AIR IS BEING BLOCKED IN THE LUNGS, CAUSING A LIFE-THREATENING INCREASE IN INTRATHORACIC PRESSURE. THIS CAUSES A DECREASE IN VENOUS RETURN AND A SHARP DROP IN BLOOD PRESSURE. THE SITUATION IS NOTICED, AND THE PATIENT IS REMOVED FROM THE MACHINE. THE BLOOD PRESSURE SOON RISES TO NORMAL, AND NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21650415 ↗
• MalfunctionMar 17, 2025Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE INTERNAL BATTERY FAILURE WHILST BEING USED ON A PATIENT. ALSO FAILING DEVICE CHECK (PEEP INOP). THE CUSTOMER REPORTED DEVICE FAILED WHILE USE ON A PATIENT. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616231 ↗
• DeathFeb 10, 2025Failure to Run on Battery; Failure to Deliver; Complete Loss of Power; Failure to Run on Battery; Failure to Deliver; Complete Loss of Power

  IT WAS REPORTED THAT THE DEVICE HAD BEEN LEFT IN DEVICE CHECK SCREEN WHILE ON CHARGE, AT SOME POINT THE MAINS LEAD HAD SEPARATED FROM THE POWER SUPPLY TO NO LONGER MAKE CONTACT. ONCE PUT INTO USE THE BATTERIES WERE FLAT. FURTHERMORE, IT WAS REPORTED BY THE USER THAT THE DEVICE' "BATTERY WENT FLAT DURING RESUSCITATION IN EU, RESULTING IN A DELAY IN PROVIDING THERAPY AS MANUAL VENTILATION VIA A BAG AND MASK WAS REQUIRED. IT IS POSSIBLE THE INCIDENT HASTENED THE PATIENT'S DEMISE BUT ONLY BY MINUTES OR AT BEST HOURS IN THE OPINION OF THE MEDICS."

  Patient problems: Hypoxia

  MAUDE report 21341858 ↗
• MalfunctionDec 20, 2024Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  THE HOSPITAL COMPLAINED THAT DURING THE TRANSFER OF A PATIENT, OXYLOG 3000 PLUS AUTOMATICALLY STOPPED VENTILATION WHEN THE POWER WAS CONNECTED, AND THE VENTILATION COULD NOT BE RESTORED AFTER THE MACHINE WAS RESTARTED. IT WAS REPORTED THAT THE PATIENT¿S SPO2 SATURATION TEMPORARILY DECREASED. NO SERIOUS INJURY WAS REPORTED. THE HOSPITAL STAFF IMMEDIATELY USED THE MANUAL AIR BAG TO VENTILATE THE PATIENT IN THE TRANSPORT VEHICLE (INFORMATION FROM UFR).

  Patient problems: Low Oxygen Saturation

  MAUDE report 20986363 ↗
• MalfunctionSep 27, 2024Failure to Run on Battery; Failure to Deliver; Complete Loss of Power; Failure to Run on Battery; Failure to Deliver; Complete Loss of Power

  IT WAS REPORTED THAT AN OXYLOG WAS TURNING OFF SPONTANEOUSLY MID PATIENT TRANSFER, WE'VE REQUESTED FURTHER INFORMATION BUT HAVE ONLY BEEN ABLE TO GET THE BELOW INFORMATION DETAILS ARE ¿LOW PHYSICAL HARM¿ EXPERIENCED BY THE PATIENT, WITH REPORTS OF LOSS OF ETCO2 AND NOT VENTILATING. IT WAS REPORTED THAT THE PATIENT¿S CONDITION TEMPORARILY DECREASED / LOW PHYSICAL HARM WAS REPORTED. NO SERIOUS INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20319735 ↗
• MalfunctionSep 19, 2024Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT DEVICE STOPPED DURING VENTILATION. AT 8:25 PATIENT WAS TAKEN TO THE HOSPITAL BY AMBULANCE AND RECEIVED CPR TREATMENT. 8:28 PATIENT WAS INTUBATED AND VENTILATION WAS STARTED. 8:28 UNTIL 9:00 PARAMEDIC CONFIRMED THE BATTERY DISCHARGE MESSAGE, AND THE BATTERY LED INDICATOR WAS GREEN AT THAT TIME. ALSO CONFIRMED THAT REMAINING CAPACITY OF THE BATTERY INDICATED ALMOST FULL (25% X 4 WERE LIT). AFTER THAT, IT WAS CONFIRMED THAT VENTILATION WAS NOT BEING PERFORMED, AND THE REMAINING CAPACITY OF THE BATTERY WAS ZERO AT THAT TIME. THE DEVICE WAS REPLACED TO ANOTHER DEVICE. NO PATIENT 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255115 ↗
• InjuryJul 25, 2024Inaccurate Flow Rate; Medical Gas Supply Problem; Output Problem; Inaccurate Flow Rate; Medical Gas Supply Problem; Output Problem

  IT WAS REPORTED THAT, DURING THE RETURN FROM A RADIOLOGICAL EXAMINATION, THE PATIENT'S OXYGEN SATURATION SUDDENLY DROPPED BECAUSE THE VENTILATION VIA THE TRANSPORT VENTILATOR WAS INSUFFICIENT. THE PATIENT HAD TO BE RESUSCITATED WHICH WAS SUCCESSFUL.

  Patient problems: Respiratory Arrest

  MAUDE report 19826052 ↗
• MalfunctionJul 8, 2024Gas Output Problem; Failure to Sense; Failure to Deliver; Gas Output Problem; Failure to Sense; Failure to Deliver

  IT WAS REPORTED THAT A ¿TECHNICAL FAILURE¿ ALARM OCCURRED WHILST IN USE ON PATIENT. REPORTEDLY, THE DEVICE WAS SWAPPED OUT. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687523 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103625. One submission often covers many models, so check the product and lot details in each record.

• Z-2018-2023 · Jun 12, 2023 · Open, Classified
  Oxylog 3000 Plus emergency and transport ventilator
• Z-0692-2016 · Dec 22, 2015 · Terminated
  Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controll
• Z-0691-2016 · Dec 22, 2015 · Terminated
  Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
• Z-1440-2014 · Mar 5, 2014 · Terminated
  Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833