Skip to content

Ascom CardiomaxRecalls & reported problems

Ascom (Sweden) AB · Class 2

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17350088670016), received between Oct 22, 2020 and Oct 22, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Use of Incorrect Control/Treatment Settings1

Patient problems

  • Low Oxygen Saturation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathOct 22, 2020Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem; Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem

    ON 25 SEPTEMBER 2020, (B)(6) UNIVERSITY HOSPITAL REPORTED THAT PRIORITY 1 ALERTS FROM SPACELABS MONITORS WERE NOT BEING RECEIVED AT ASCOM WIRELESS HANDSETS. THE SITE REPORTED A DEATH AND THE SITE INDICATED THE PERFORMANCE OF ASCOM'S CARDIOMAX SYSTEM PLAYED A PART IN THE FAILURE OF THESE ALERTS BEING COMMUNICATED TO THE HANDSETS. PER OUR REGIONAL CUSTOMER SUPPORT MANAGER, 28 SEPTEMBER 2020, INITIAL COMMUNICATION CAME FROM ASCOM'S DISTRIBUTOR, PRIMARY SYSTEMS INC., VIA EMAIL ON 26 SEPTEMBER 2020. PRIMARY SYSTEMS INDICATED THAT THERE WAS A SENTINEL EVENT AT (B)(6) UNIVERSITY HOSPITAL. PRIMARY SYSTEMS REPORTED THAT ASCOM'S CARDIOMAX ASSIGNMENTS MODULE DID NOT PICK UP ASSIGNMENTS FROM THE RAULAND-BORG NURSE CALL SYSTEM. PRIMARY SYSTEMS WAS ABLE TO VERIFY THAT THE ALARM CAME INTO ASCOM CARDIOMAX FROM THE SPACELABS SYSTEM AND THAT THE RAULAND-BORG SYSTEM SENT STAFF ASSIGNMENTS TO ASCOM. THEY INDICATED THAT OUR DEVELOPMENT TEAM WAS NOTIFIED LATE FRIDAY 25 SEPTEMBER 2020 AND HAD BEEN ENGAGED IN INVESTIGATING THE ISSUE. ASCOMS CARDIOMAX SYSTEM FORWARDS ALERTS AND ALARMS FROM THE SPACELABS MONITORS TO ASCOM WIRELESS HANDSETS CARRIED BY THE CLINICAL STAFF. THE INTENDED USE OF ASCOM CARDIOMAX I

    Patient problems: Low Oxygen Saturation

    MAUDE report 10720594 ↗

Other System,Network And Communication,Physiological Monitors devices

All System,Network And Communication,Physiological Monitors devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.