ELI 380 ELI380-DCS11Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00812345026917), received between Aug 4, 2020 and Aug 16, 2026 — classified as 1 death, 2 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (46 reports).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K142105); 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. Nov 11, 2020Terminated

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

   Z-0553-2021 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• InjuryNov 14, 2024Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED THAT DURING THE USE OF THE ELI 380, THE DEVICE WOULD NOT PRINT AND DISPLAYED A PAPER QUEUE FAULT ERROR. THE CUSTOMER REPORTED THE PATIENT HAD BEEN ADMITTED FOR ABNORMAL HEART RATE AND MYOCARDITIS AND AT THE TIME OF THE EVENT THE PATIENT WAS NOTED TO BE BRADYCARDIC. A CODE WAS INITIATED, AND AN ECG WAS REQUESTED. AT THAT TIME THE ELI 380 DID NOT PRINT. THEREFORE, A STAFF MEMBER OBTAINED AN ALTERNATE ECG DEVICE FROM A NEIGHBORING AREA, THUS RESULTING IN A 3-MINUTE DELAY IN OBTAINING THE ALTERNATE DEVICE AND IDENTIFYING THAT THE PATIENT WAS IN 2ND DEGREE HEART BLOCK, WHICH COULD NOT BE IDENTIFIED ON THE FACILITY¿S 3RD PARTY MONITORING DEVICE. SIMILARLY, IT WAS REPORTED THAT PRIOR TO OBTAINING THE ALTERNATE DEVICE, BASED ON THE PATIENT¿S CLINICAL STATUS, THE DECISION WAS MADE TO QUICKLY TRANSFER THE PATIENT TO A HIGHER LEVEL OF CARE, INCLUDING THE CARDIAC CATHETERIZATION LAB AND ICU. THE CUSTOMER CONFIRMED THAT NO INJURY OCCURRED, HOWEVER, INDICATED THAT A DELAY IN CARE AND CLINICAL DECISION MAKING OCCURRED AS A RESULT OF THIS EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Arrhythmia; Myocarditis

  MAUDE report 20686202 ↗
• MalfunctionOct 29, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED NETWORK ISSUES AND BEING UNABLE TO TRANSMIT DATA. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER BAXTER COMPLAINT REF # (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556405 ↗
• MalfunctionSep 23, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THE ELI380 WHEN MOVED FROM 1 PART OF THE HOSPITAL TO ANOTHER, LOSES ITS CONNECTION. IT WAS ADDITIONALLY REPORTED THAT THE UNIT GAVE A BAD READING. THERE WAS NO PATIENT HARM REPORTED. THIS INCIDENT HAS BEEN CAPTURED UNDER COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279451 ↗
• MalfunctionJul 30, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED WIFI CONNECTIVITY ISSUES WITH THE ELI380 UNIT. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860110 ↗
• MalfunctionJul 18, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THE ELI380 WAS HAVING INCONSISTENT CONNECTION ISSUES. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770433 ↗
• MalfunctionJul 9, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED HAVING ONGOING CONNECTIVITY ISSUES WITH THE ELI380 UNIT. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700906 ↗
• MalfunctionJun 26, 2024Wireless Communication Problem; Wireless Communication Problem

  THE BIOMED AT THE FACILITY REPORTED THAT THE ELI380 UNIT INTERMITTENTLY LOSES CONNECTIVITY TO THE WLAN. IT WAS REPORTED THE CONNECTION DROPPED FOR 45 MINUTES, DEVICE SHOWED NO SIGNAL AND WAS UNABLE TO DOWNLOAD ANY ORDERS. IT WAS ADDITIONALLY REPORTED THAT THE SCREEN INTERMITTENTLY SHOWS FUZZY STATIC. THERE WAS NO ADVERSE EVENT REPORTED AS A RESULT OF THIS EVENT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615009 ↗
• MalfunctionMay 1, 2024Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT ECG RECORDS WERE JUMPING TO DIFFERENT INCORRECT PATIENTS ON THE ELI380 CARTS. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219365 ↗
• MalfunctionMay 1, 2024Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT ECG RECORDS WERE JUMPING TO DIFFERENT INCORRECT PATIENTS ON THE ELI380 CARTS. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219343 ↗
• MalfunctionMay 1, 2024Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT ECG RECORDS WERE JUMPING TO DIFFERENT INCORRECT PATIENTS ON THE ELI380 CARTS. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER BAXTER COMPLAINT REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219335 ↗
• MalfunctionApr 4, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT ELI380 WAS HAVING INTERMITENT NETWORK ISSUES. 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 19046114 ↗
• MalfunctionFeb 29, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI380 WAS INTERMITTENTLY DROPPING WIFI CONNECTION AND NOT TRANSMITTING DATA. THIS COMPLAINT WAS CAPTURED UNDER HILLROM REF (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806430 ↗
• MalfunctionJan 30, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE ELI380 HAS HAD PERSISTENT NETWORK ISSUES. IT WILL GO FROM HAVING A STRONG SIGNAL TO A WEAK SIGNAL OR NO SIGNAL. THERE WAS NO ASSOCIATED INJURY REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606807 ↗
• MalfunctionNov 30, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED A NUMBER OF ISSUES WITH THE ELI380 INCLUDING THE WIRED AND WIRELESS NETWORK CONNECTIONS WOULD SIMPLY STOP WORKING BUT THEN COME BACK WITH NO ACTION TAKEN. THE CUSTOMER ALSO STATED THAT WHEN ANY OF THOSE CONDITIONS OCCUR, THE SCREEN GOES BLANK. THERE WAS NO ASSOCIATED ADVERSE EVENT REPORTED WITH THIS COMPLAINT. THIS INCIDENT WAS CAPTURED UNDER HILL-ROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236782 ↗
• MalfunctionAug 23, 2023Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THEIR ELI 380 RESTING ELECTROCARDIOGRAPH READINGS WERE INCORRECT, PARTICULARLY THE CORRECTED QT (QTC) VALUE OF 430, AND ¿THE PATIENT SUBSEQUENTLY WENT INTO CARDIAC ARREST RELATED TO INAPPROPRIATE TIKOSYN ADMINISTRATION BASED ON QTC MEASUREMENT.¿ THE CUSTOMER REPORTED THAT THE DEVICE INTERPRETED THE PATIENT¿S QTC VALUE AS 430 AND THE PHYSICIAN CALCULATED THE QTC VALUE AS OVER 500. FOLLOW-UP WITH THE CUSTOMER CONFIRMED THAT THERE WERE NO ALTERATIONS IN THE PATIENT¿S PLAN OF CARE ASSOCIATED WITH THE RESULTS FROM THE ECG PERFORMED AT 1038 ALONG WITH THE HOSPITALIST¿S ¿WET READ¿ OF SAID ECG AT THAT SAME TIME. ADDITIONALLY, THE CUSTOMER REPORTED THAT NO SUBSEQUENT PRESCRIBED DOSES OF TIKOSYN WERE ADMINISTERED AND THAT THIS ECG WAS PERFORMED, PER FACILITY PRACTICE, TWO HOURS FOLLOWING THE LAST ADMINISTRATION OF TIKOSYN (PO AT 0913, Q12HOURS) TO DETERMINE IF THE NEXT PRESCRIBED DOSE IS INDICATED. BASED ON ADDITIONAL INFORMATION FROM THE CUSTOMER THAT NO MEDICAL DECISIONS WERE MADE TO CHANGE THE COURSE OF TREATMENT BASED ON THE ECG ¿WET READ¿ BY THE HOSPITALIST AND THE SEQUENCE OF EVENTS REPORTED TO HAVE OCCURRED ON 21JUL2023 (TIKOSYN GIVEN 0913, ECG PERFORMED 103

  Patient problems: Cardiac Arrest

  MAUDE report 17604669 ↗
• MalfunctionMay 5, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE DEVICE IS INTERMITTENTLY NOT CONNECTING TO THE WLAN NETWORK. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875014 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142105. One submission often covers many models, so check the product and lot details in each record.

• Z-1013-2023 · Oct 31, 2022 · Terminated
  Baxter Electrocardiograph, ELI 380 -DCS21
• Z-1483-2021 · Mar 31, 2021 · Terminated
  ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediat
• Z-1796-2015 · May 29, 2015 · Terminated
  ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously a