Perseus A500 MK06000Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 04048675253600), received between Mar 23, 2017 and Sep 25, 2026 — classified as 3 deaths, 10 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (90 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K133886); 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. Mar 20, 2024Open, Classified

   Unexpected shutdown while operating on battery power.

   Z-1512-2024 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Gas Output Problem

  It was reported that the device issued a data loss alarm and after about 10 minutes, the screen went blank briefly before restarting and signaling that the flow sensors required calibration. No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894922 ↗
• InjuryAug 7, 2026Gas Output Problem; Unexpected Therapeutic Results; Human-Device Interface Problem

  It was reported that the patient developed obvious signs of a significant desaturation (cyanosis) whereupon the users noticed that the anesthesia workstation was in Standby and not ventilating. As per report, ventilation support was bridged manually until a SYSTEM TEST was passed successfully and ventilation could be started. The desaturation was reportedly removed quickly after re-establishing ventilation, preventing from final health consequences.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50171526 ↗
• MalfunctionMay 27, 2026Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE INDUCTION OF THE PATIENT IN MANUAL VENTILATION WAS UNEVENTFUL BUT THAT - SOON AFTER SWITCHOVER TO AUTOMATIC VENTILATION, THE ANESTHESIA DEVICE ALARMED, THE SCREEN TURNED BLACK AND VENTILATION STOPPED. AS PER REPORT, THE EMERGENCY GAS SUPPLY HAS WORKED, THE DEVICE WAS REPLACED AND THE EVENT DID NOT RESULT IN HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301791 ↗
• MalfunctionMay 22, 2026Gas Output Problem; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THERE WAS A VENTILATOR FAILURE DURING USE. THE DEVICE GENERATED AN ALARM. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253136 ↗
• MalfunctionMay 11, 2026Human-Device Interface Problem; Output Problem

  IT WAS REPORTED THAT "THE TOUCHSCREEN MALFUNCTIONED DURING MACHINE OPERATION, MAKING IT IMPOSSIBLE TO ADJUST PARAMETERS." THERE WAS NEITHER AN INDICATION FOR A PATIENT INVOLVEMENT NOR AN INJURY OR HEALTH IMPAIRMENT IN THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134642 ↗
• MalfunctionMay 11, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING ANESTHESIA, THE SCREEN FROZE JUST AFTER THE FRESH GAS FLOW WAS INCREASED. THERE WAS NO RESPONSE FROM THE SCREEN. A FEW SECONDS LATER, THE SCREEN TURNED WHITE FOLLOWED BY A RESTART FROM THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134641 ↗
• MalfunctionMay 11, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING ANESTHESIA, A LOUD ALARM SOUND WAS HEARD, LOW AIR AND O2 SUPPLY WAS DISPLAYED. THE SCREEN FROZE AND THERE WAS NO CO2 CURVE, AND THE PATIENT WAS NOT VENTILATED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134639 ↗
• MalfunctionMay 7, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE PERSEUS FAILED DURING USE AND CONTINUED OPERATION AFTER APPROX. 10 SECONDS WITH AN ALARM MESSAGE INDICATING THAT THE FLOWSENSOR WAS NOT CALIBRATED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25109965 ↗
• MalfunctionMay 5, 2026Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure

  IT WAS REPORTED THAT ON (B)(6) 2026, AT 14:44 PM, DURING OPERATION, THE PERSEUS WAS NOT POSSIBLE TO OPERATE ANYMORE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078176 ↗
• MalfunctionApr 29, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE PERSEUS SCREEN TURNED WHITE AND, SHORTLY AFTERWARDS, AN ERROR MESSAGE APPEARED STATING THAT THE FLOW SENSORS NEEDED TO BE CALIBRATED. THE OPERATION WAS SUCCESSFULLY PERFORMED USING THE PERSEUS. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027523 ↗
• MalfunctionApr 24, 2026Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING ANESTHESIA, THERE IS SUDDENLY A VERY LOUD ALARM SOUND, AFTER WHICH THE ANESTHESIA MACHINE SHUTS DOWN, THE CONTROL PANEL GOES COMPLETELY BLACK AND THE VENTILATION STOPS. IT IS VERY BRIEF - LESS THAN 2 MINUTES - BEFORE THE ENTIRE SYSTEM RESTARTS AUTOMATICALLY. THE PATIENT HAS NOT LACKED VENTILATION AT ANY TIME. THERE HAVE BEEN NO CHANGES IN THE PATIENT'S MEASURED VALUES. THE PATIENT WAS ENSURED OXYGEN ALL THE TIME. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979000 ↗
• MalfunctionApr 22, 2026No Display/Image; Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE SCREEN TURNED BLANK, THEN THE DEVICE PERFORMED A WARM START DURING SURGERY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954038 ↗
• MalfunctionApr 17, 2026Erratic or Intermittent Display; Sensing Intermittently; Failure to Deliver

  IT WAS REPORTED THAT THE VENTILATOR FAILED DURING USE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909217 ↗
• MalfunctionApr 17, 2026Erratic or Intermittent Display; Sensing Intermittently; Failure to Deliver

  IT WAS REPORTED THAT THE VENTILATOR FAILED DURING USE. THERE WAS N INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909216 ↗
• MalfunctionApr 16, 2026Gas Output Problem; Failure to Deliver; Inaccurate Delivery

  IT WAS REPORTED: "DURING THE ANAESTHESIA OF AN 18-YEAR-OLD MALE PATIENT IN OPERATION NORTH 2, THE DEPARTMENT OF ANAESTHESIA & SURGERY NORTH, AARHUS UNIVERSITY HOSPITAL, A LOUD WHINING NOISE SUDDENLY EMANATED FROM THE ANAESTHESIA MACHINE, AND THE ENTIRE SCREEN WENT BLACK. THE FAULT LASTED APPROX. 3 SECONDS AND RECURRED TWICE DURING THE ANAESTHESIA. AFTER THE TWO EPISODES, THE SCREEN RETURNED TO NORMAL DISPLAY, ALTHOUGH SOME OF THE FIGURES APPEARED LIGHT GREY. THE MACHINE THEN DISPLAYED A MESSAGE STATING "FLOW SENSOR CALIBRATION REQUIRED". THE DEVICE HAD PREVIOUSLY BEEN TESTED AND USED ON SEVERAL PATIENTS WITHOUT ANY PROBLEMS. DURING THE PERIODS OF MALFUNCTION, THE ANAESTHESIA SYSTEM¿S FUNCTION WAS TEMPORARILY UNAVAILABLE, WHICH COULD POTENTIALLY HAVE RESULTED IN A FAILURE TO DETECT CHANGES IN THE PATIENT¿S CONDITION OR IN THE COMPOSITION OF THE ANAESTHETIC GAS. CONSEQUENCES WERE AVOIDED BECAUSE ACTION WAS TAKEN.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902352 ↗
• MalfunctionApr 14, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING USE. THE VENTILATOR SCREEN WENT BLUE AND THE VENTILATOR THEN PERFORMED A RESTART AND OPERATED NORMALLY WITH PRE-SET ADJUSTMENTS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868790 ↗
• MalfunctionMar 18, 2026Gas Output Problem; Decrease in Pressure; Reset Problem

  IT WAS REPORTED THAT THE DEVICE FAILED DURING USE. AN INTERNAL FG FLOW FAILURE AND A SYSTEM FAILTURE ALARM WERE GENERATED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631696 ↗
• MalfunctionMar 13, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Inaccurate Delivery; Gas/Air Leak

  IT WAS REPORTED THAT THE MACHINE VENTILATOR WOULD RUN AND STOP WITH A BREAK IN-BETWEEN. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588856 ↗
• InjuryMar 10, 2026Gas Output Problem; Inaccurate Delivery; Misassembled During Installation

  IT WAS REPORTED THAT THE VAPORIZER WAS NOT SEATED PROPERLY LOCKED DOWN. THE PATIENT WAS AWAKE DURING PROCEDURE. POST-OP THE PATIENT RECEIVED ADDITIONAL MEDICATION TO ASSIST WITH THE ¿DISCOMFORT/EXPERIENCE¿.

  Patient problems: Emotional Changes

  MAUDE report 24556179 ↗
• MalfunctionMar 4, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WITHOUT COMPLICATIONS. MANUAL VENTILATION WAS USED INITIALLY, THEN SWITCHED TO MECHANICAL VENTILATION. SUDDENLY, A BEEPING SOUND WAS HEARD, ACCOMPANIED BY A SIMULTANEOUS FAILURE OF THE VENTILATION AND DISPLAY. THE ALARMING AND EMERGENCY DOSING WERE STILL FUNCTIONAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504532 ↗
• MalfunctionFeb 23, 2026Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure

  IT WAS REPORTED THAT ON (B)(6) AT APPROXIMATELY 2:52 PM, THE PERSEUS RESTARTED UNEXPECTEDLY DURING ANESTHESIA, AFTER APPROXIMATELY 3¿3½ HOURS OF USE. BEFORE RESTARTING, THE PERSEUS PLAYED AN ACOUSTIC ALARM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412606 ↗
• MalfunctionFeb 19, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT AUTOMATIC VENTILATION WAS INTERRUPTED WHILE THE DEVICE PERFORMED A RESTART. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385619 ↗
• MalfunctionJan 12, 2026Gas Output Problem; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE DEVICE SCREEN FROZE AND COULD NOT BE OPERATED DURING A CASE. THE DEVICE EMITTED A LOUD INTERMITTENT HIGH-FREQUENCY BEEPING. THE PATIENT WAS IMMEDIATELY VENTILATED MANUALLY AND A REPLACEMENT DEVICE WAS USED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035676 ↗
• MalfunctionDec 8, 2025Circuit Failure; Gas Output Problem; Failure to Deliver; Circuit Failure; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE STOPPED VENTILATING AND ALARMED FOR ¿TURBOVENT 2 FAILURE.¿ THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740461 ↗
• MalfunctionDec 8, 2025Circuit Failure; Gas Output Problem; Failure to Deliver; Circuit Failure; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE STOPPED VENTILATING AND ALARMED FOR ¿TURBOVENT 2 FAILURE.¿ THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739991 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133886. One submission often covers many models, so check the product and lot details in each record.

• Z-2254-2018 · May 24, 2018 · Terminated
  Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manu
• Z-0360-2016 · Nov 12, 2015 · Terminated
  Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-suppo