Shp Unt Infinity Central Station MS18384Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049098050449), received between Aug 31, 2022 and Jun 28, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K061379, K130711); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A PATIENT WITH A SHORT TERM TOTAL BLOCK WITH SYMPTOMS WHO NEEDED TELEMETRY MONITORING COULD NOT BE MONITORED DUE TO TECHNICAL ISSUES AND TROUBLESHOOTING ONGOING IN THE TELEMETRY UNITY. THE SPECIFIC MALFUNCTION OF THE TELEMETRY WAS NOT PROVIDED. THE PATIENT WAS TEMPORARILY MOVED OUT INTO THE CORRIDOR. IT WAS CONFIRMED THAT THAT THE PATIENT DOES DID NEED TO RETURN TO HIA AT THE TIME. THE REPORT STATES THAT THE ICU HAD NOT BEEN INFORMED OF THE TELEMETRY MALFUNCTIONS. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Heart Problem

  MAUDE report 19632383 ↗
• MalfunctionDec 27, 2022No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT DURING AN EVENT WHERE THE INVOLVED PATIENT DIED, THE NURSE NOTICED THAT THE PATIENT HR WENT >120, TACHYCARDIA AND UP TO 237BPM BUT NO AUDIBLE ALARMS WERE PROVIDED AT THE INFINITY CENTRAL STATION (ICS). THOUGH THE INVOLVED PATIENT DIED, THERE IS NO ALLEGATION THE ICS BEHAVIOR CAUSED A DELAY IN TREATMENT/PLAYED A PART IN THE PATIENT OUTCOME. INFINITY M300 (SERIAL NUMBER (B)(4)) PATIENT WORN MONITOR WAS BEING USED WITH THE ICS.

  Patient problems: Cardiac Arrest; Tachycardia

  MAUDE report 16051788 ↗
• MalfunctionDec 22, 2022No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT DURING A PATIENT EVENT IN THE CARDIAC WARD NO AUDIBLE ALARM WAS PROVIDED AT THE INFINITY CENTRAL STATION (ICS), ONLY VISUAL. IT WAS NOTED THAT TACHYCARDIA, PAUSE AND BRADYCARDIA ALARMS WERE ALL SET TO MEDIUM PRIORITY. IN THE CARDIAC WARD THE ICS IS MONITORED 24/7 TO WATCH THE PATIENTS. NO ADVERSE PATIENT IMPACT WAS REPORTED. INFINITY M300 PATIENT WORN MONITOR (SERIAL NUMBER (B)(4) WAS BEING USED WITH THE ICS. THE ICS IS THE PRIMARY ALARM SOURCE FOR THE M300.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 16039752 ↗
• MalfunctionAug 31, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  INITIALLY IT WAS REPORTED THAT AN EVENT WAS NOT RECORDED ON THE INFINITY CENTRAL STATION (ICS) (DEVICE MODEL MS25707, SERIAL NUMBER (B)(4). NOTE THAT ALARMS AT THE ICS ARE PROVIDED FROM THE ASSOCIATED PATIENT WORN/BEDSIDE MONITORS. IN THIS CASE, THE ASSOCIATED M300 (DEVICE MODEL MS25755, SERIAL NUMBER (B)(4) WAS IN THE BEDSIDE CHARGER. ON (B)(6) 2022 NEW INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WENT INTO SVT (SUPRAVENTRICULAR TACHYCARDIA) AND THE MONITOR DID NOT PROVIDE AN ALARM. A DOCTOR WAS AT THE INFINITY CENTRAL STATION (ICS) LOOKING AT ALARM HISTORIES FOR HIS PATIENT'S AND HE ALERTED THE STAFF WHEN HE SAW THE SVT ON THE MONITOR. NO DELAY IN TREATMENT/ADVERSE PATIENT IMPACT WAS REPORTED. A FAILURE TO ALARM COULD RESULT IN DELAYED INTERVENTION IF TREATMENT IS REQUIRED.

  Patient problems: Tachycardia

  MAUDE report 15331336 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061379, K130711. One submission often covers many models, so check the product and lot details in each record.

• Z-1012-2022 · Mar 4, 2022 · Open, Classified
  Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
• 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