BCI WW1030ENRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of BCI (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a BCI pulse oximeter from ICU Medical, a bedside device that reads a patient's blood oxygen level and pulse. The 34 reports mostly describe alarm and display problems — alarms that fail to sound, stay very quiet, sound intermittently, or read low and differ from other monitors, along with lost readings and error messages. No deaths or injuries were reported, and 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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 30843418000191), received between Jun 29, 2018 and Aug 13, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Alarm System8
- Defective Alarm4
- No Visual Prompts/Feedback4
- Incorrect, Inadequate or Imprecise Result or Readings3
- Material Integrity Problem3
- Key or Button Unresponsive/not Working2
- Mechanical Problem2
- Output Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information3
- Not Applicable2
- No Consequences Or Impact To Patient1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Fire; Temperature Problem
It was reported that the AC adapter caught fire and the plastic piece that goes into the bottom in the device melted. When the BCI Spectro2 Pulse Oximeter was connected to the AC adapter, the facility had noticed a burning smell followed by a plastic smell. The facility immediately investigated and observed that the connector was hot to touch, the plastic connector was melted and the metal at the connector was burnt. It burned the night stand too. There were patient involvement and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241671 ↗MalfunctionJan 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THERE WAS A NUMERICAL ABNORMALITY. THE EVENT OCCURRED DURING PATIENT USE, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 18539800 ↗MalfunctionJan 18, 2024Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE DEVICE HAS ABNORMALITY TO ITS NUMERICAL VALUE. THERE WAS KNOWN PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 18539790 ↗MalfunctionMay 10, 2023Device Alarm System; Erratic or Intermittent Display; Device Alarm System; Erratic or Intermittent Display
IT WAS REPORTED, THAT THE DEVICE WAS ALARMING INTERMITTENLY. REPEAT POWER UP, KEYPAD FAIL, AND SHOW ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16901604 ↗MalfunctionMar 28, 2023Low Audible Alarm; Low Audible Alarm
IT WAS REPORTED THAT THE DEVICE HAD A VERY QUIET ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16632709 ↗MalfunctionOct 4, 2022Defective Alarm; Defective Alarm
IT WAS REPORTED THAT THE DEVICE IS ALARMING AND READING LOW O2 WHEN ANOTHER UNIT WAS READING NORMALLY WITH THE SAME PATIENT. 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 15536716 ↗MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE CUSTOMER DID NOT HAVE A CONSTANT READINGS MEANING THAT THEY WERE LOSING READINGS DURING TESTING. ALSO, THEY HAVE NOTICED WITH PATIENTS THAT HAVE COMPROMISED CIRCULATION IT WOULD NOT GIVE READINGS AT ALL. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15328913 ↗MalfunctionAug 31, 2022No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT THE TOP LIGHT NOT ALARMING WHEN ACTIVATED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15328237 ↗MalfunctionAug 31, 2022No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THE TOP LIGHT DOES NOT FLASH WHEN ALARMING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15328159 ↗MalfunctionAug 31, 2022No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT THE LIGHT DOES NOT FLASH. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327038 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE IS DISPLAYING ERROR MESSAGE WARRANTY. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327006 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING ERROR MESSAGE WARRANTY. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326820 ↗MalfunctionAug 31, 2022High Readings; High Readings
IT WAS REPORTED THAT THERE WAS AN HIGH READINGS ISSUE WITH THE REPORTED DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326760 ↗MalfunctionAug 31, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DEVICE IS GIVING AN ERROR LED THAT LIGHTS UP. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326757 ↗MalfunctionAug 31, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DEVICE IS GIVING ERROR CODE 18. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326683 ↗MalfunctionAug 31, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DEVICE IS PRESENTING WITH SENSOR ERROR. THE SENSORS WERE CHANGED AND THE DEVICE STILL GAVE AN ERROR. WHEN THE SENSOR WERE USED ON DIFFERENT DEVICE, THEY OPERATED PROPERLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326673 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE IS DISPLAYING ERROR MESSAGE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326472 ↗MalfunctionAug 31, 2022Defective Alarm; Mechanical Problem; Defective Alarm; Mechanical Problem
IT WAS REPORTED THAT THE DEVICES ALARM BUTTON IS NOT WORKING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326464 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE REJECTED BY PULMOLINK AT GOODS INWARDS ACCEPTANCE TESTING DISPLAYING "10 ERR". NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326463 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE INCORRECT REPLACEMENT AND STILL NEED THEIR ORIGINAL DEVICE REPLACED. THE RECEIVED DEVICE IS SHOWING ERROR ON THE MONITOR. THEY REMOVED AND REINSERTED THE BATTERIES AA PER THE MANUAL. THE ERROR DID NOT CLEAR SO THE MONITOR WAS RETURN TO US FOR A WARRANTY CLAIM. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326446 ↗MalfunctionAug 30, 2022Device Alarm System; Mechanical Problem; Device Alarm System; Mechanical Problem
IT WAS REPORTED THAT THE DEVICE WHEN SIMULATING A HIGH PRIORITY ALARM SITUATION, THE RED LIGHT-EMITTING DIODE (LED) WARNING BEACON FAILED TO ILLUMINATE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322844 ↗MalfunctionAug 30, 2022Data Problem; Data Problem
IT WAS REPORTED THAT THERE WAS AN INCORRECT READING ISSUE WITH THE REPORTED DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322719 ↗MalfunctionAug 30, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE ALARM BUTTON OF THE DEVICE WAS NOT WORKING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320796 ↗MalfunctionAug 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE MACHINE WAS READING CONTINUOUSLY WITHOUT STOPPING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320195 ↗MalfunctionAug 30, 2022Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT THE DEVICE WAS SHOWING INCORRECT READING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320170 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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