ELI 380Recalls & reported problems across all models

We found 11 models of ELI 380 by Mortara Instrument, Inc. in the FDA's device registry (GUDID). Together they are named in 109 adverse event reports in the FDA's MAUDE database, received between Aug 4, 2020 and Aug 16, 2026 — classified as 1 death, 3 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (71 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ELI 380 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 31, 2021Terminated

   Devices do not meet IEC 60601-2-27 requirements as labeled.

   Z-1483-2021 · Root cause: Process control · Recall details · FDA record ↗

2. Nov 11, 2020Terminated

   The radio within the device can become disassociated with the wireless access point.

   Z-0553-2021 · Root cause: Software design · names 9 of these models · Recall details · FDA record ↗

Most reported ELI 380 problems

ELI 380 models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ELI 380 ELI380-DCS11

  Electrocardiograph
  1 recall1 death70 reports
• ELI 380 ELI380-DCX11

  Electrocardiograph
  1 recall12 reports
• ELI 380 ELI380-ACX11

  Electrocardiograph
  1 recall8 reports
• ELI 380 ELI380-DCX21

  Electrocardiograph
  1 recall6 reports
• ELI 380 ELI380-DCS21

  Electrocardiograph
  1 recall5 reports
• ELI 380 ELI380-ACX21

  Electrocardiograph
  1 recall3 reports
• ELI 380 ELI380-ACS11

  Electrocardiograph
  1 recall2 reports
• ELI 380 ELI380-DCS43

  Electrocardiograph
  1 recall1 report
• ELI 380 ELI380-DAX3X

  Electrocardiograph
  1 recall0 reports
• ELI 380 ELI380-DCX43

  Electrocardiograph
  1 recall0 reports
• ELI 380 ELI380-ACS21

  Electrocardiograph
  2 reports

Recent ELI 380 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026Overheating of Device

  Baxter received a report stating that an ELI380 had a burn mark above the touchpad on the top right. This occurred before use. There was no patient injury or death reported with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267639 ↗
• MalfunctionAug 16, 2026Overheating of Device

  Baxter received a report stating that an ELI380 had a burn mark above the touchpad on the top right. This occurred before use. There was no patient injury or death reported with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263556 ↗
• MalfunctionMay 18, 2026Patient Data Problem

  THE CUSTOMER CONTACTED BAXTER TO REPORT THAT PATIENT DEMOGRAPHICS WERE SWITCHING WHEN SAVING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211570 ↗
• InjuryNov 25, 2025Inaccurate Information; Inaccurate Information

  IT WAS INITIALLY REPORTED THAT THE ELI 380 RESTING ELECTROCARDIOGRAPH READINGS WERE MISCALCULATING THE QTC AND THE PATIENT WENT INTO CARDIAC ARREST. THE CUSTOMER REPORTED THAT THE DEVICE INTERPRETED THE PATIENT¿S QTC VALUE AS 440 AND THE PHYSICIAN CALCULATED THE QTC VALUE AS 501.

  Patient problems: Cardiac Arrest

  MAUDE report 23642927 ↗
• MalfunctionOct 16, 2025Overheating of Device; Overheating of Device

  CUSTOMER REPORTED THAT THE POWER BUTTON WAS GETTING HOT AND APPEARED TO BE BURNING A HOLE THROUGH THE MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308212 ↗
• MalfunctionAug 25, 2025Wireless Communication Problem; Wireless Communication Problem

  CUSTOMER REPORTED DEVICE WOULD DROP WIFI CONNECTION AND WOULD NOT RECONNECT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882263 ↗
• MalfunctionAug 18, 2025Wireless Communication Problem; Wireless Communication Problem

  CUSTOMER REPORTED INTERMITTENT WIFI CONNECTIONS. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825230 ↗
• MalfunctionJul 3, 2025Wireless Communication Problem; Wireless Communication Problem

  CUSTOMER REPORTED THE CONNECTION ISSUES. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394389 ↗
• MalfunctionMay 26, 2025Wireless Communication Problem; Wireless Communication Problem

  CUSTOMER REPORTED CART NOT COMMUNICATING VIA WIRELESS. THIS COMPLAINT WAS CAPTURED UNDER HILLROM REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083809 ↗
• MalfunctionApr 24, 2025Wireless Communication Problem; Wireless Communication Problem

  CUSTOMER REPORTED WIFI DROPPING. THIS COMPLAINT WAS CAPTURED UNDER BAXTER REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898010 ↗
• MalfunctionMar 17, 2025Wireless Communication Problem; Wireless Communication Problem

  CUSTOMER REPORTED DEVICE IS HAVING ISSUES CONNECTING TO THE WIRELESS LAN. THIS COMPLAINT WAS CAPTURED UNDER HILLROM REF #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625026 ↗
• MalfunctionJan 2, 2025Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THE ED UNIT IS REPEATEDLY UNABLE TO TRANSMIT DUE TO BUTTONS BEING GREYED OUT ON THE ELI380. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053155 ↗
• MalfunctionNov 27, 2024Computer Software Problem; Computer Software Problem

  CUSTOMER REPORTED PATIENT RECORD MISMATCH. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796362 ↗
• MalfunctionNov 25, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE WIRELESS CARD WAS NOT WORKING. THE UNIT CONSTANTLY LOSES ITS IP ADDRESS. THERE WAS NO INJURY REPORTED. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770500 ↗
• MalfunctionNov 18, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI380 WAS NOT TRANSMITTING PROPERLY. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704810 ↗

Other Mortara Instrument, Inc. products

• Q-Stress17 models · 12 reports · 2 recalls
• XScribe Cardiopulmonary Kit3 models · 0 reports · 2 recalls
• HScribe8 models · 1 reports · 1 recall
• RScribe5 models · 0 reports · 1 recall
• XScribe2 models · 0 reports · 1 recall
• Vision Express4 models · 0 reports · 1 recall
• AM12M3 models · 0 reports · 1 recall
• Surveyor S192 models · 0 reports · 1 recall