Carina System 8419350Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04048675041610), received between May 4, 2017 and Jun 2, 2026 — classified as 2 deaths, 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K072885); 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.

Recalls naming this device

1. Jul 12, 2023Open, Classified

   Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

   Z-2248-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED THAT THE CARINA VENTILATOR TRIGGERED A TECHNICAL ALARM. THE ALARM OCCURRED WHILE THE DEVICE WAS CONNECTED TO THE PATIENT. ACCORDING TO THE USER, A BACKUP VENTILATOR WAS IMMEDIATELY AVAILABLE. THE PATIENT¿S OXYGEN SATURATION SUBSEQUENTLY STABILIZED AGAIN. NO FURTHER COMPLICATIONS OR MEDICAL INTERVENTIONS INVOLVING THE PATIENT WERE REPORTED.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25358724 ↗
• MalfunctionMar 31, 2026Circuit Failure; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT THE AFFECTED CARINA VENTILATOR TRIGGERED A TECHNICAL ALARM. THE ALARM OCCURRED WHILE THE DEVICE WAS CONNECTED TO THE PATIENT. ACCORDING TO THE USER, THE DEFECTIVE CARINA WAS REPLACED IMMEDIATELY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743530 ↗
• MalfunctionFeb 24, 2026Gas Output Problem; Unexpected Therapeutic Results; Human-Device Interface Problem

  IT WAS REPORTED THAT THE INHALATION THERAPIST SAW ON THE "TECHNICAL PROBLEM" SCREEN THAT THE DISPLAY WAS NO LONGER RESPONDING AND THE ON/OFF BUTTON WAS NOT WORKING. THE INHALATION THERAPIST HAD TO UNPLUG THE DEVICE TO TURN IT OFF. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425581 ↗
• MalfunctionFeb 24, 2026Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED THAT DURING USE, THE CARINA STOPPED WORKING MID-VENTILATION ON A PATIENT. THE BATTERY WAS CHARGED AND UNPLUGGED; IT STARTED UP FINE ON BATTERY POWER AND HELD THE CHARGE. CUSTOMER IS AFRAID IT MIGHT BE A MAJOR PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425578 ↗
• MalfunctionJan 12, 2026Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power

  IT WAS REPORTED THAT THE DEVICE SWITCHED OFF DURING OPERATION WITH A CONTINUOUS TONE AND A A WHITE SCREEN INCL. ALARM MESSAGE. THE DEVICE IMMEDIATELY ACTIVATED A CONTINUOUS HIGH-PITCHED ALARM. THE USER WAS ABLE TO REACT IN TIME AND PROVIDE A REPLACEMENT DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035514 ↗
• MalfunctionJan 17, 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, WHILE BEING ON PATIENT TRANSPORT, THE VENTILATOR SUDDENLY ALARMED, THEN POWERED OFF AND COULD NOT BE TURNED ON AGAIN. THE PATIENT WAS IMMEDIATELY VENTILATED BY A BREATHING BAG AND RE-CONNECTED TO ANOTHER VENTILATOR - NO INJURY OR SERIOUS IMPAIRMENT OF PATIENTS STATE OF HEALTH WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21176987 ↗
• MalfunctionMay 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE SUDDENLY "STOPPED RUNNING". AS PER REPORT, THE PATIENT EXPERIENCED A TEMPORARY DESATURATION WHICH WAS REMOVED QUICKLY AFTER THE INTRODUCTION OF A REPLACEMENT DEVICE. NO HEALTH CONSEQUENCES HAVE OCCURRED, FINALLY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 19257973 ↗
• MalfunctionApr 3, 2024Gas Output Problem; No Device Output; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; No Device Output; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED THAT: NURSE WITH A STUDENT TAKING PATIENT FOR A CT SCAN OF THE BODY. PATIENT UNDER SUPERVISION IN OPTIFLOW. DOCTOR DECIDED THAT THE PATIENT WILL BE TRANSPORTED USING NIV WITH PREVIOUS SETTINGS. CARINA USED WITH HUMIDIFIER HOSES. BEFORE TRANSPORT THE PATIENT HAD TIME TO BE ON NIV FOR A WHILE OXYGENATION WAS GOOD, THE PATIENT TOLERATED NIV WELL. CHECKED OXYGEN BOTTLE-> OPEN AND ENOUGH OXYGEN IN THE BOTTLE. THERE WERE NO PROBLEMS BEFORE TRANSPORTATION. THE NURSE WAS TOLD TO WAIT FOR THE TT TO BE RELEASED. SURPRISINGLY, AFTER A WHILE, THE NIV STARTS FLASHING RED TO WARN OF DEVICE MALFUNCTION! EVERYTHING (HOSES) WERE QUICKLY CHECKED. CARINA AND HUMIDIFIER WERE PLUGGED INTO THE MAINS. THE PROBLEM DIDN'T GO AWAY, AND SOON THE PATIENT STARTS TEARING OFF THE MASK AND SAYS HE CAN'T GET OXYGEN. REMOVED THE PATIENT'S MASK FROM THE GAP AND QUICKLY RETURNED TO CONTROL, WHERE ANOTHER CARINA WAS REPLACED WITH OTHER DEVICE. FORTUNATELY, THE PATIENT WAS QUICKLY RESTORED TO OXYGEN SUPPORT. THE SITUATION RESULTED IN AN UNPLEASANT SITUATION FOR THE PATIENT, WHERE HE HAD TO EXPERIENCE SEVERE SHORTNESS OF BREATH AND THE FEELING OF RUNNING OUT OF OXYGEN FOR A WHILE. THE SITUATION WAS QUICK

  Patient problems: Dyspnea

  MAUDE report 19034895 ↗
• MalfunctionMar 8, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO THE SUB ACUTE VENTILATOR AND VENTILATED WHILE BEING TRANSPORTED FOR AN EXTERNAL EXAMINATION. ON THE WAY BACK TO THE DEPARTMENT THE VENTILATOR SUDDENLY SHOWED A WHITE SCREEN AND DID NOT WORK NORMAL. THE PATIENT WAS IMMEDIATELY SUPPORTED BY A BREATHING BAG AND CONNECTED TO ANOTHER VENTILATOR AT ARRIVAL ON THE WARD. NO INJURY OR SERIOUS IMPAIRMENT OF PATIENT´S STATE OF HEALTH WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18864959 ↗
• DeathDec 27, 2023Gas Output Problem; Inaccurate Delivery; Gas Output Problem; Inaccurate Delivery

  IT WAS REPORTED THAT THE DEVICE ALARMED AND SWITCHED TO BACKUP VENTILATION DURING USE. THE VENTILATION WAS PERFORMED WITH SETTINGS FOR APNEA. IT WAS REPORTED THAT VITALS WERE DETERIORATING. IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY TWO HOURS AFTER THE EVENT, BUT THE CONNECTION TO THE EVENT HAS NOT BEEN SPECIFIED.

  Patient problems: Insufficient Information

  MAUDE report 18397121 ↗
• MalfunctionDec 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE POSTED ACOUSTICAL AND VISUAL ALARMS INDICATING A DEVICE MALFUNCTION. THE USERS REPLACED THE DEVICE IN A CONTROLLED MANEUVER; NO PATIENT CONSEQUENCES HAVE REPORTEDLY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355654 ↗
• InjurySep 8, 2023Gas Output Problem; No Device Output; Failure to Deliver; Misassembly by Users; Gas Output Problem; No Device Output; Failure to Deliver; Misassembly by Users

  IT WAS REPORTED THAT A PATIENT IN SERIOUS HEALTH CONDITION NEEDED TO BE TRANSFERRED TO ANOTHER HOSPITAL FOR SPECIAL TREATMENT. THE PATIENT WAS VENTILATED BY A ¿SUB ACUTE CARE¿ VENTILATOR IN AN AMBULANCE VEHICLE AND - AFTER 20 MINUTES OF TRANSPORT, THE VENTILATOR GENERATED AN ALARM INDICATING AN ¿EQUIPMENT FAILURE¿ - RESTART OF THE VENTILATOR REPORTEDLY DID NOT SOLVE OR IMPROVE THE SITUATION. AFTER DISCONNECTION, THE PATIENT WAS SUPPORTED BY MANUAL VENTILATION USING A BREATHING BAG. THE PATIENT BECAME UNCONSCIOUS, MEDICINES WERE GIVEN AND RESCUE/RESUSCITATION PROCEDURE WAS STARTED ¿ HOWEVER LATER-ON THE PATIENT DIED IN A NEARBY HOSPITAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17709853 ↗
• MalfunctionSep 27, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE, THE DEVICE GENERATED ALARM AND STOPPED VENTILATION - EXCHANGE TO THE STANDBY EQUIPMENT IMMEDIATELY. NO INJURY OR SERIOUS IMPAIRMENT OF HEALTH OF THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493291 ↗
• InjurySep 8, 2022Disconnection; Failure to Run on Battery; Failure to Deliver; Complete Loss of Power; Disconnection; Failure to Run on Battery; Failure to Deliver; Complete Loss of Power

  IT WAS REPORTED THAT THE DEVICE'S POWER CORD WAS NOT FULLY PLUGGED IN, CAUSING THE INTERNAL BATTERY TO DISCHARGE. THE DEVICE ALARMED AND SHUT DOWN WHILE IN USE. AS A RESULT, THE PATIENT SUFFERED A STROKE AND WILL NOT RECOVER, ACCORDING TO THE HOSPITAL. BASED ON THE ON-SITE INSPECTION OF THE DEVICE, BATTERY AND LOG BY DRÄGER SERVICE, A MALFUNCTION OF THE DEVICE CAN BE EXCLUDED.

  Patient problems: Stroke/CVA

  MAUDE report 15376959 ↗
• MalfunctionSep 6, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE, THE DEVICE GENERATED ALARM AND STOPPED VENTILATION - EXCHANGE TO THE STANDBY EQUIPMENT IMMEDIATELY. NO INJURY OR SERIOUS IMPAIRMENT OF HEALTH OF THE PATIENT REPORTED. AFTER THE REPORTED EVENT THE USER SWITCHED ON THE DEVICE AGAIN, NO MALFUNCTION REOCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361606 ↗
• MalfunctionJun 23, 2022Gas Output Problem; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED DURING USE THE CARINA HAD SHUT DOWN. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14785770 ↗
• MalfunctionFeb 10, 2022Gas Output Problem; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED DURING USE THE CARINA HAD SHUT DOWN. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS SWITCHED TO ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13504989 ↗
• MalfunctionJan 6, 2022Gas Output Problem; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED THAT THE CARINA DEVICE GENERATED THE ALARM MESSAGE "DEVICE ERROR" TWICE AT AROUND 11.32 P.M. ON THE (B)(6) 2021 AND AS A RESULT VENTILATION WAS NO LONGER POSSIBLE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176027 ↗
• MalfunctionOct 27, 2021Gas Output Problem; Failure to Deliver; Inaccurate Delivery; Gas Output Problem; Failure to Deliver; Inaccurate Delivery

  IT WAS REPORTED THAT THERE WAS A DEVICE FAILURE DURING AN ONGOING NIV VENTILATION OF THE PATIENT. THE DEVICE GENERATED A "TECHNICAL ALARM" MESSAGE, BUT VENTILATION OF THE PATIENT WAS NO LONGER POSSIBLE. THE AFFECTED DEVICE WAS IMMEDIATELY REPLACED BY THE STAFF ON SITE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703789 ↗
• MalfunctionMar 10, 2021Use of Device Problem; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Use of Device Problem; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  PATIENT WAS CONNECTED TO THE VENTILATOR AND NIV USED SEVERAL HOURS. UNIT WAS CONNECTED TO MAINS ALL THE TIME. PATIENT TRANSPORT STARTED AND UNIT ALARMED NO EXTERNAL POWER CONNECTED, USES INTERNAL BATTERY AS NORMALLY. AFTER APR. 5 MIN OF BATTERY OPERATION, THE UNIT SHUT DOWN WITHOUT ANY WARNING OR ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454801 ↗
• MalfunctionFeb 24, 2021Gas Output Problem; Failure to Deliver; Gas/Air Leak; Gas Output Problem; Failure to Deliver; Gas/Air Leak

  IT WAS REPORTED THAT THE CARINA DISPLAYED A TECHNICAL ALARM DURING USE ON A PATIENT IN COMBINATION WITH AN OPTICAL AND ACOUSTICAL ALARM. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11371416 ↗
• MalfunctionAug 13, 2020Gas Output Problem; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  PLEASE REFER TO THE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10400526 ↗
• MalfunctionMay 28, 2020Gas Output Problem; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  PLEASE REFER TO THE INITIAL-REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10094993 ↗
• MalfunctionMar 27, 2020Gas Output Problem; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED THAT A PATIENT WAS CONNECTED TO THE CARINA TO SUPPORT PATIENT'S BREATHING, CARINA STARTED TO WORK NORMALLY BUT SUDDENLY THE DEVICE INFORMED MALFUNCTION AND STOPPED OPERATION. CARINA SHUT DOWN AND RESTARTED. IT RESTARTED FOR SECONDS AND SHUT DOWN BY ITSELF. THIS HAPPENED SEVERAL TIMES. PATIENT SATURATION WAS LOW AS 80% AND BELOW, AND PATIENT HAD DIFFICULTIES TO BREATH SO CPAP WAS REALLY NEEDED. NEW CARINA WAS BROUGHT FOR PATIENT AND IT WORKED NORMALLY. PATIENT HAD FEW MINUTES BREAK IN CPAP TREATMENT. NO FURTHER CONSEQUENCES REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 9887641 ↗
• MalfunctionNov 6, 2019Failure to Deliver; No Pressure; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THE UNIT SHUT DOWN AND THEN RESTARTED DURING A CASE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9283896 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072885. One submission often covers many models, so check the product and lot details in each record.

• Z-1954-2018 · Apr 26, 2018 · Terminated
  Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.