INFINITY CENTRAL STATION MS18500Recalls & reported problems
Draeger Medical Systems, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049098004190), received between Jul 26, 2023 and Dec 26, 2024 — classified as 1 death, 4 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem1
- Device Handling Problem1
- Fire1
- No Audible Prompt/Feedback1
- Patient Data Problem1
- Under-Sensing1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Unspecified Heart Problem1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2024Under-Sensing; 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21018757 ↗DeathNov 7, 2024No Audible Prompt/Feedback; Device Handling Problem; No Audible Prompt/Feedback; Device Handling Problem
ON OCTOBER 30TH, THE FSE RECEIVED A SERVICE CALL TO CHECK THE ALARMS AT THE INFINITY CONTROL CENTER (ICS). WHILE ON SITE THE CUSTOMER INFORMED THE FSE THAT A PATIENT HAD SUFFERED A CARDIAC INCIDENT ON OCTOBER 25TH AROUND 5:30. THE PATIENT WAS FOUND IN THEIR ROOM WITH THE M300 ALARMING, AND WAS TRANSFERRED TO THE CARDIOLOGY INTENSIVE CARE UNIT, THERE THE PATIENT PASSED AWAY. THE CUSTOMER REPORTED THAT THE M300 DID NOT ALARM ACOUSTICALLY AT THE ICS, AND SUSPECTED THAT SOME OF THE ALARM WERE NOT WORKING PROPERLY.
Patient problems: Unspecified Heart Problem
MAUDE report 20629771 ↗MalfunctionMay 21, 2024Patient Data Problem; Patient Data Problem
THE CUSTOMER REPORTED THAT THE ICS SYSTEM DOES NOT ALLOW THE STAFF TO ADMIT PATIENTS TO THE SYSTEM, AND THAT IS THE ADMISSION IS SUCCESSFUL, THE PATIENT INFORMATION MAY DISAPPEAR. THE CUSTOMER REPORTED THAT THE PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2024, AND DID NOT REPORT ANY PATIENT INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359688 ↗MalfunctionOct 6, 2023Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE INFINITY CENTRAL STATION (ICS) SHUT-DOWN DUE TO AN ACCIDENTAL POWER LOSS. AS PER REPORT, THE MONITORING OF THE INDIVIDUAL PATIENTS VIA THEIR BEDPLACE MONITORS WAS NOT INTERRUPTED; THE EVENT DID NOT HAVE MEDICAL CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17884039 ↗MalfunctionJul 26, 2023Fire; Fire
THE HOSPITAL BIOMED REPORTED THAT SMOKE WAS COMING FROM THE INFINITY CENTRAL STATION (ICS). UPON FURTHER INVESTIGATION HE FOUND THAT THE DVD DRIVE CABLE HAD BEEN MELTED. HE INDICATED HE DISCONNECTED THE DVD CABLE FROM POWER SUPPLY. BUT STILL HAS THE ICS IN USE. THERE WAS NO INDICATION OF FIRE REPORTED. NO ADVERSE PATIENT IMPACT WAS REPORTED. ON (B)(6) 2023 THE HOSPITAL BIOMED LATER REPORTED THAT THE CABLE ITSELF BURNT TO A CRISP. HE REMOVED THE DVD PLAYER AND BOOTED THE SYSTEM BACK UP. IF THE SYSTEM EVER NEEDS A SOFTWARE RELOAD, THEN I GUESS I WILL NEED A NEW DVD, PLAYER AND CABLE BOTH WERE BURNT UP PRETTY BAD. THIS IS THE 3RD ICS I HAVE SEEN IN THE LAST 15 YEARS CATCH FIRE AT THAT CABLE CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17399547 ↗
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
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- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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