BCI WW1000ENRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical oximeter is a patient monitor used to track vital signs during hospital care. The 28 reports mostly describe the unit showing error codes on screen, triggering alarms, failing to power up or shut off, and software and sensor reading problems, including one report of an incorrect value while monitoring a patient. No deaths or injuries are described. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 30843418000016), received between Apr 26, 2019 and Sep 9, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (9 reports).
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.
Reports received per month
Most reported problems
Device problems
- Device Alarm System9
- Computer Software Problem3
- Device Sensing Problem3
- Failure to Power Up2
- Image Display Error/Artifact2
- Defective Device1
- Detachment of Device or Device Component1
- Failure to Shut Off1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information2
- No Patient Involvement2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE WAS SHOWING ERROR OF "SR ERR". THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007307 ↗MalfunctionMay 1, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE WAS SHOWING A SENSOR ERROR MESSAGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942506 ↗MalfunctionJan 15, 2025No Device Output; No Device Output
IT WAS REPORTED THAT UPON POWER UP "CAN'T GET PAST THE CODE. TRIED TO RESTART THE DEVICE DIDN'T FIX THE ISSUE. GOT ERROR ERR 18 OXIM_INIT". NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158241 ↗MalfunctionJan 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE MONITORING DEVICE PRODUCED THE INCORRECT VALUE. EVENT OCCURRED WHILE IN USE WITH THE PATIENT, DURING PATIENT ADMINISTRATION. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21069285 ↗MalfunctionMay 7, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE WAS SHOWING THE ERROR-17 BEFORE INFUSION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19265055 ↗MalfunctionJan 10, 2023Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE DEVICE SHOWS ERROR MESSAGE? SR ERR ALL THE TIME. NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16131165 ↗MalfunctionOct 13, 2022Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT THE DEVICE GAVE A P55 ERROR. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15600970 ↗MalfunctionOct 13, 2022Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT THERE WAS A PO22 CODE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15600902 ↗MalfunctionSep 1, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE IS DISPLAYING ERROR MESSAGE "SERVICE ERROR". NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15335386 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327013 ↗MalfunctionAug 31, 2022Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE IS DISPLAYING SENSOR ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327009 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING ERROR MESSAGE WHEN PROBE IS ATTACHED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326490 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE IS DISPLAYING ERROR 18. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326488 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE IS SHOWING AN ERROR ON TOP SCREEN BY LED LIGHTS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326484 ↗MalfunctionAug 30, 2022Computer Software Problem; Computer Software Problem
IT WAS REPORTED THE DEVICE WAS GETTING AN ERROR CODE OF E25. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320374 ↗MalfunctionAug 30, 2022Failure to Shut Off; Inaccurate Information; Failure to Shut Off; Inaccurate Information
IT WAS REPORTED THAT THE DEVICE WAS NOT READING CORRECTLY AND WON'T TURN OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320118 ↗MalfunctionJul 26, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE IS SHOWING AN ERROR ON TOP SCREEN BY LED LIGHTS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15108850 ↗MalfunctionJul 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FINGER SENSOR CABLE COVERING WAS SEPARATING FROM THE PLUG AND EXPOSING SOME WIRING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14922504 ↗MalfunctionFeb 25, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE DEVICE WAS GETTING ERROR CODE 5R WITH TWO DIFFERENT SENSORS. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13603475 ↗MalfunctionFeb 10, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE PROBE STOPPED WORKING, LOOSE WIRES. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13506697 ↗MalfunctionJan 27, 2022Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE CUSTOMER HAS TROUBLE GETTING READINGS. IT IS NOT HOLDING A SIGNAL WELL. WHEN WE DO GET A READING IT DOES NOT SEEM TO BE ACCURATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13366390 ↗MalfunctionOct 30, 2021Device Alarm System; Device Alarm System
IT WAS REPORTED THAT IS NON-FUNCTIONAL, AND ALL THE LIGHTS ARE LIT UP CONSTANTLY. THE CUSTOMER IS UNABLE TO OBTAIN A READING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12724972 ↗MalfunctionSep 19, 2021Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE DEVICE WAS BLINKING "SR ERR" AND THE ON OFF SWITCH WAS PUSHED IN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12493442 ↗MalfunctionAug 12, 2021Device Alarm System; Device Alarm System
IT WAS REPORTED THAT A SENSOR ISSUE WAS INDICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315860 ↗MalfunctionOct 11, 2019Intermittent Communication Failure; Intermittent Communication Failure
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL SLEEP CAPNOGRAPH HAS ERROR SR. IT WAS REPORTED UNIT WAS FOUND ON SHELF; IT FAILED ANNUAL INSPECTION. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9181909 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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