Infinity CentralStation Wide (confi) MS26800Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04049098001878), received between Nov 19, 2021 and Nov 10, 2025 — classified as 1 death, 30 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (6 reports).

3 FDA recall records name this device's identifier, 3 still open.

1 other recall cover devices cleared under the same FDA submission (K130711, K231477, K240312); 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. Jan 14, 2025Open, Classified

   Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.

   Z-1066-2025 · Root cause: Device Design · FDA record ↗

2. Apr 5, 2023Open, Classified

   The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

   Z-1471-2023 · Root cause: Software design · FDA record ↗

3. Mar 4, 2022Open, Classified

   Software issue resulting in temporary loss of central monitoring functionality.

   Z-1012-2022 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Telemetry Discrepancy; Communication or Transmission Problem; Telemetry Discrepancy; Communication or Transmission Problem

  IT WAS REPORTED THAT THE M300 TELEMETRY MONITOR WAS DISCHARGING ON ITS OWN WITHOUT ANY USER INTERACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509863 ↗
• MalfunctionNov 4, 2025Telemetry Discrepancy; Communication or Transmission Problem; Telemetry Discrepancy; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE M300 MONITOR IS DISCHARGED A PATIENT AUTOMATICALLY WITHOUT USER INITIATION. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465793 ↗
• MalfunctionOct 22, 2025Telemetry Discrepancy; Communication or Transmission Problem; Telemetry Discrepancy; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE M300 MONITOR IS DISCHARGED A PATIENT AUTOMATICALLY WITHOUT USER INITIATION. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359662 ↗
• MalfunctionAug 13, 2025Computer Software Problem; Unexpected Shutdown; Computer Software Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE INFINITY CENTRAL STATION (ICS) UNEXPECTANTLY RESTARTED DURING THE EXPORT OF LOGFILES USING THE UNIVERSAL SERIAL BUS (USB) PORT ON THE FRONT OF THE HOUSING. PATIENT MONITORING WAS INTERRUPTED AT THE ICS DURING THE RESTART, BUT MONITORING CONTINUED AT ALL LOCAL MONITORING DEVICES THAT WERE CONNECTED TO THE ICS AT THE TIME OF THIS EVENT. THE USB PORT IN THE REAR OF THE HOUSING WAS THEN USED TO EXPORT THE LOGFILES AND THE DEVICE BEHAVED AS EXPECTED.. ADDITIONALLY, THIS RESULTED IN A CORRUPT LOG FILE THAT COULD NOT BE OPENED. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796512 ↗
• MalfunctionJul 10, 2025Communication or Transmission Problem; Wireless Communication Problem; Communication or Transmission Problem; Wireless Communication Problem

  THE INFINITY M300 PATIENT MONITORS WERE REPORTED TO HAVE DISCHARGED FROM THE INFINITY CENTRAL STATION (ICS) WITHOUT ANY USER INTERACTION. ACCORDING TO THE CUSTOMER, THE ICS DISPLAYED A ¿DISCHARGE¿ MESSAGE AT THE TIME OF THE EVENT, WHILE ALL PATIENT DATA REMAINED ACCESSIBLE IN THE TREND TAB. THE M300 MONITORS WERE SUCCESSFULLY READMITTED, ALLOWING PATIENT MONITORING TO CONTINUE WITHOUT INTERRUPTION. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475438 ↗
• MalfunctionJul 10, 2025Communication or Transmission Problem; Wireless Communication Problem; Communication or Transmission Problem; Wireless Communication Problem

  THE INFINITY M300 PATIENT MONITORS WERE REPORTED TO HAVE DISCHARGED FROM THE INFINITY CENTRAL STATION (ICS) WITHOUT ANY USER INTERACTION. ACCORDING TO THE CUSTOMER, THE ICS DISPLAYED A ¿DISCHARGE¿ MESSAGE AT THE TIME OF THE EVENT, WHILE ALL PATIENT DATA REMAINED ACCESSIBLE IN THE TREND TAB. THE M300 MONITORS WERE SUCCESSFULLY READMITTED, ALLOWING PATIENT MONITORING TO CONTINUE WITHOUT INTERRUPTION. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475300 ↗
• MalfunctionJul 10, 2025Communication or Transmission Problem; Wireless Communication Problem; Communication or Transmission Problem; Wireless Communication Problem

  THE INFINITY M300 PATIENT MONITORS WERE REPORTED TO HAVE DISCHARGED FROM THE INFINITY CENTRAL STATION (ICS) WITHOUT ANY USER INTERACTION. ACCORDING TO THE CUSTOMER, THE ICS DISPLAYED A ¿DISCHARGE¿ MESSAGE AT THE TIME OF THE EVENT, WHILE ALL PATIENT DATA REMAINED ACCESSIBLE IN THE TREND TAB. THE M300 MONITORS WERE SUCCESSFULLY READMITTED, ALLOWING PATIENT MONITORING TO CONTINUE WITHOUT INTERRUPTION. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473721 ↗
• MalfunctionJan 23, 2025Loss of Data; Unexpected Shutdown; Loss of Data; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE (ICS) INFINITY CENTRAL STATION REBOOTED ON ITS OWN. APPROXIMATELY TWO HOURS LATER THE STAFF NOTICED THE TRENDS AND FULL DISCLOSURE WERE MISSING. IN ADDITION, IT WAS REPORTED THAT THE ASSOCIATED BEDSIDE MONITOR IS A (M300) TELEMETRY. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217447 ↗
• MalfunctionDec 19, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE (ICS) INFINITY CENTRAL STATION REBOOTED. WHEN THE (ICS) REBOOTS THERE IS NO PATIENT MONITORING AT THE CENTRAL. IN ADDITION, IT WAS REPORTED THAT THE ASSOCIATED BEDSIDE MONITOR (M300) DID NOT MONITOR A PATIENT DURING THE ICS REBOOT. A LOSS OF MONITORING AT THE CENTRAL AND BEDSIDE MAY DELAY PATIENT TREATMENT AND CARE AND HAS THE POTENTIAL FOR AN ADVERSE EVENT TO OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20978066 ↗
• MalfunctionDec 18, 2024Failure to Transmit Record; Loss of Data; Failure to Transmit Record; Loss of Data

  IT WAS REPORTED THAT A LOSS OF FULL DISCLOSURE DATA WAS NOTICED ON THE INFINITY CENTRAL STATION WHEN THE CLINICIAN TRIED TO RETRIEVE THE PATIENT DATA. A LOSS OF FULL DISCLOSURE PATIENT DATA COULD IMPACT A CLINICIAN'S ABILITY TO FULLY DIAGNOSE AND OR TREAT A PATIENT. DRAEGER HAS STARTED AN INVESTIGATION, A FOLLOW UP WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETE.

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

  MAUDE report 20965728 ↗
• MalfunctionOct 29, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE ALARM LIMITS AT THE INFINITY CENTRAL STATION (ICS) COULD NOT BE CHANGED ON THE NIGHT OF SEPT 16 - 17TH. REPORTEDLY, THE ALARM LIMITS COULD NOT BE ADJUSTED TO SUIT THE PATIENT, AND THE DEVICES PROVIDED UNNECESSARY AND EXCESSIVE ALARMING. THIS ISSUE OCCURRED FOR THE TELEMETRY UNITS REGISTERED ON THE ICS. ONE INSTANCE OF THE DEVICE ALARMING WAS WHEN THE HEART RATE LIMITS COULD ONLY BE SET TO 20/MIN OR 70/MIN AS THE LOWER LIMIT FOR HEART RATE AND 120/MIN OR 200/MIN AS THE UPPER LIMIT, WITH NO OTHER OPTIONS. ONE PATIENT HAD 500 BRADYCARDIA ALARMS IN FOUR HOURS , AND THE PROBLEM ALSO CAUSED ALARMS TO RING CONTINUOUSLY THROUGHOUT THE NIGHT FOR SEVERAL PATIENTS. THE CUSTOMER REPORTED THAT THE "REAL ALARMS" WERE NOT AS EFFECTIVELY DETECTED AMONG THE "UNNECESSARY" RINGING, AND THAT A BRADYCARDIA (22/MIN) WAS MISSED, BUT THE NURSES DETECTED THE ISSUE. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

  Patient problems: Bradycardia

  MAUDE report 20557866 ↗
• MalfunctionSep 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE INFINITY CENTRAL STATION "STOPPED" ON (B)(6), 8:3PM. NO DETAILS ON THE NATURE OF THE "STOP" WAS PROVIDED. IT WAS THEN RESTARTED AT 9:53 PM. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT OR PATIENT DEATH.

  Patient problems: Insufficient Information

  MAUDE report 20339137 ↗
• MalfunctionSep 12, 2024Inappropriate Audible Prompt/Feedback; No Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THERE WAS NO SP02 AUDIO ALARMS AT THE CENTRAL STATION, ONLY VISUAL ALARMS. THE DRAEGER TECHNICIAN CONFIRMED THIS REPORT. THE TECHNICIAN FOUND THAT THE ALARM SETTINGS ON THE CENTRAL HAD BEEN CHANGED, AND CHANGED THE SETTINGS. ONCE THE SETTINGS WERE CHANGED, THE AUDIBLE ALARMS IMMEDIATELY FUNCTIONED AS INTENDED. IT WAS REPORTED THAT THE CUSTOMER'S TECHNICAL SUPPORT AND CLINICAL HAD NOT BEEN AWARE THAT THIS SETTING CHANGE WAS POSSIBLE. THE PATIENT WAS REPORTEDLY IN THEIR ROOM, AND THE CUSTOMER STATES THAT THERE WAS NO DELAY TO PATIENT TREATMENT AND NO PATIENT INJURY. THERE WAS NO ADVERSE PATIENT IMPACT OR DEATH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20205099 ↗
• MalfunctionJul 8, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE TELEMETRY MONITOR DID NOT ALARM FOR A SHORT VENTRICULAR TACHYCARDIAC EVENT THAT LASTED 9 BEATS WHILE THE ALARM WAS SET TO MEDIUM. THE EVENT WAS SHOWN TO BE STORED AS AN EVENT AT THE ICS. THE ARRYTHMIA WAS WITNESSED BY THE STAFF PRESENT AT THE BEDSIDE. ADDITIONALLY, THE CUSTOMER REPORTED THAT PATIENT INFORMATION WAS MISSING, BUT DID NOT CONFIRM WHAT PATIENT INFORMATION. NO PATIENT HARM OR ADVERSE PATIENT IMPACT WAS REPORTED. SINCE THE REPORTED MALFUNCTION, THE DEVICE HAS CORRECTLY ALARMED.

  Patient problems: Tachycardia

  MAUDE report 19690424 ↗
• MalfunctionJun 28, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT AT 2130 IT IS NOTED THAT THE TELEMETRY ONLY SHOWS VISUAL ALARMS, NO AUDIBLE ALARM SOUND IS HEARD, ALTHOUGH THE SOUND VOLUME IS AT 100 PERCENT. IT IS UNCLEAR HOW LONG THIS HAS BEEN THE CASE. EARLIER IN THE DAY, THE CONTROL CENTER FOR THE TELEMETERS WAS CHANGED. THERE IS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632542 ↗
• MalfunctionJun 28, 2024Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE PATIENT DATA AFTER A HIGH FREQUENCY OF 150 BPM WAS NOT ABLE TO BE REVIEWED IN THE TREND. THE CUSTOMER CONFIRMED THAT THE BEDSIDE MONITOR CONTINUED TO REAL TIME MONITORING. THE CUSTOMER REPORTED THAT THE INABILITY TO REVIEW THE HISTORICAL TREND OF THE EVENT COULD POTENTIALLY IMPACT DIAGNOSIS AND TREATMENT. THE USER SWITCHED OUT THE TELEMETRY UNITY TO AMEND THE ISSUE. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information; Unspecified Heart Problem

  MAUDE report 19632481 ↗
• MalfunctionJun 28, 2024Telemetry Discrepancy; Inaudible or Unclear Audible Prompt/Feedback; Output Problem; Telemetry Discrepancy; Inaudible or Unclear Audible Prompt/Feedback; Output Problem

  THE CUSTOMER REPORTED THAT ECG ALARMS/EVENTS ARE NOT RECORDED, AND THAT PATIENT DATA IS MISSING. ADDITIONALLY, THE CUSTOMER REPORTED THAT, AFTER UPDATING THE CENTRAL TELEMETRY SYSTEM, THE VOLUME OF ALARMS IS MUCH LOWER THAN BEFORE, AND COULD NOT BE CHANGED, STATING THAT USERS DO NOT REACT TO THE NEW ALARMS. ADDITIONALLY, THE UPDATE CHANGED THE DEFAULT SETTINGS FOR THE ALARM LIMITS. THE CUSTOMER CONFIRMED NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632475 ↗
• MalfunctionJun 28, 2024Insufficient Device Problem Information; Wireless Communication Problem; Insufficient Device Problem Information; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE TELEMETRY PATIENT INFORMATION WAS NOT DISPLAYED AT THE CENTRAL FOR HOURS AFTER THE PATIENT WAS CONNECTED TO THE TELEMETRY UNIT, AND THAT NO ALARMS AND EVENTS WERE REGISTERED, AND NO ANALYSIS OF THE PATIENT HEART WAS ABLE TO BE CONDUCTED DURING THAT TIME. AFTER THE USERS EXCHANGED THE TELEMETRY UNITY, REAL TIME MONITORING WAS RESTORED. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632470 ↗
• MalfunctionMay 24, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE USB CONNECTION CABLE OF THE DRÄGER KEYBOARD IS BURNT, AND THAT THE CUSTOMER REPLACED THE KEYBOARD WITH A NON-DRAEGER KEYBOARD. THERE WAS NO REPORT OF ANY PATIENT OR USER INJURY OR DEATH.

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

  MAUDE report 19391830 ↗
• MalfunctionMay 17, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE M300 PLUS MADE A BEEP, REBOOTED A FEW TIMES AND THEN THE PATIENT WAS DISCHARGED ON THE CENTRAL. THE CUSTOMER CHANGED THE BATTERY AND ARE KEEPING THE DEVICE IN USE. NO REPORT OF PATIENT INJURY OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340974 ↗
• MalfunctionApr 22, 2024No Audible Prompt/Feedback; No Visual Prompts/Feedback; No Audible Prompt/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED THAT THE INFINITY CENTRAL STATION FAILED TO ALARM FOR VENTRICULAR TACHYCARDIA ON (B)(6) AND (B)(6). THERE WAS NO REPORT OF PATIENT INJURY OR PATIENT DEATH.

  Patient problems: Tachycardia

  MAUDE report 19153155 ↗
• MalfunctionJan 30, 2024No Audible Alarm; Under-Sensing; No Audible Alarm; Under-Sensing

  IT WAS REPORTED THAT THE USERS BECAME AWARE THAT THE EXTERNAL LOUDSPEAKERS FOR THE INFINITY CENTRAL MONITORING STATION WILL STAY INACTIVE AFTER RETURN OF ELECTRICAL POWER FOLLOWING AN OUTAGE OR DISCONNECTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED FOR THE PARTICULAR CASE.

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

  MAUDE report 18604341 ↗
• MalfunctionJan 29, 2024No Audible Alarm; Under-Sensing; No Audible Alarm; Under-Sensing

  THE CUSTOMER REPORTED THAT THE POWER SUPPLY TO THE EXTERNAL ACTIVE SPEAKERS, SUPPLIED BY DRÄGER FOR THE ICS (EDIFIER R19UMKII) IS BRIEFLY DISCONNECTED. THE SPEAKERS AUTOMATICALLY GO INTO "USB MODE". ONCE THE POWER SUPPLY IS RESTORED, THE RED LED ON THE LOUDSPEAKER LIGHTS UP AND THE LOUDSPEAKERS NO LONGER OUTPUT ANY SOUND. THERE WAS NO ADVERSE EVENT OR PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596568 ↗
• MalfunctionJan 22, 2024Sparking; Sparking

  IT WAS REPORTED TO DRAEGER THAT CABLE OF THE COMPUTER MOUSE USED IN CONNECTION WITH THE CENTRAL MONITOR STATION ICS EXHIBITED A SHORT CIRCUIT AND WAS SPARKING. THE EVENT DID NOT LEAD TO HEALTH CONSEQUENCES FOR ANY PERSON.

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

  MAUDE report 18552587 ↗
• MalfunctionDec 21, 2023Capturing Problem; Capturing Problem

  THERE WAS NO SPECIFIC EVENT REPORTED - THE USER FACILITY STATED THAT THEY WERE UNABLE TO ESTABLISH 12-LEAD ECG MONITORING FOR CRITICAL PATIENTS PROPERLY. THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT HEALTH CONSEQUENCES FOR A PATIENT MAY HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370716 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130711, K231477, K240312. One submission often covers many models, so check the product and lot details in each record.

• Z-0372-2020 · Oct 9, 2019 · Open, Classified
  Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301