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BCI WW1030P1ENRecalls & reported problems

Icu Medical, Inc. · Class 2

All models of BCI (31)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30843418001211), received between Jun 30, 2019 and Sep 6, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “No Visual Prompts/Feedback” (2 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 18, 2026.

Most reported problems

Device problems

  • No Visual Prompts/Feedback2
  • Output Problem2
  • Break1
  • Defective Alarm1
  • Display Difficult to Read1
  • Fire1
  • Incorrect, Inadequate or Imprecise Result or Readings1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • No Consequences Or Impact To Patient1
  • No Information1
  • No Patient Involvement1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 6, 2022Break; Break

    IT WAS REPORTED THAT THE TOP FLASHING LED LIGHT IS NOT WORKING. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15363720 ↗
  • MalfunctionAug 30, 2022No Visual Prompts/Feedback; No Visual Prompts/Feedback

    IT WAS REPORTED THAT THE TOP FLASHING LED LIGHT IS NOT WORKING. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15322840 ↗
  • MalfunctionAug 30, 2022Defective Alarm; Mechanical Problem; Defective Alarm; Mechanical Problem

    IT WAS REPORTED THAT THE LIGHT ON TOP OF THE DEVICE WILL NOT WORK WHEN ALARMING. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15321541 ↗
  • MalfunctionAug 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    IT WAS REPORTED THAT THE DEVICE IS GIVING INACCURATE READINGS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15320890 ↗
  • MalfunctionAug 23, 2022No Visual Prompts/Feedback; No Visual Prompts/Feedback

    IT WAS REPORTED THE TOP LIGHT DOES NOT FLASH. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15277345 ↗
  • MalfunctionNov 26, 2019Display Difficult to Read; Output Problem; Display Difficult to Read; Output Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BCI OXIMETER SPECTRO2 - WW1000 SERIES LED LIGHT WAS NOT WORKING. THE REPORTER STATED THE EVENT OCCURRED DURING TESTING.

    Patient problems: No Patient Involvement

    MAUDE report 9377146 ↗
  • MalfunctionNov 26, 2019Output Problem; Output Problem

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BCI OXIMETER SPECTRO2 - WW1000 SERIES TOP ALARM LIGHT WAS NOT WORKING. THE REPORTER DECLINED TO PROVIDE ANY FURTHER INFORMATION.

    Patient problems: No Information

    MAUDE report 9377144 ↗
  • MalfunctionJun 30, 2019Fire; Power Problem; Temperature Problem; Fire; Power Problem; Temperature Problem

    IT WAS REPORTED THAT THE BCI OXIMETER (SPECTRO2) NO LONGER WORKED WITH AA BATTERIES OR A POWER CORD. THE AC POWER CORD ALSO CAUGHT FIRE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8746932 ↗

Other Oximeter devices

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Sources and updates

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