BCI WW1000A1ENRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30843418000283), received between Aug 20, 2021 and Sep 19, 2022 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (17 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2022Difficult or Delayed Positioning; Incorrect, Inadequate or Imprecise Result or Readings; Difficult or Delayed Positioning; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE HAD ERRATIC READING WITH THREE MAIN ISSUES: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. EAR AND FINGER READINGS WERE AT LEAST 2 PERCENT DIFFERENT, NEW PLETH WAS TRIED, BUT TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME HAD THE SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445136 ↗
• MalfunctionSep 6, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A TRAIL CARRIED OUT FOLLOWING REPORTS OF ERRATIC READING, 3 MAIN ISSUES WERE: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. THE READINGS WERE VERY ERRATIC EAR AND FINGER READING AT LEAST 2 PERCENT DIFFERENT, TRIED NEW PLETH TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS, ALSO BLOOD GAS MONITOR TESTED AGAINST. THE SECOND MODEL WE TRIALED HAD MORE STABLE READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362964 ↗
• MalfunctionSep 2, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A TRAIL CARRIED OUT FOLLOWING REPORTS OF ERRATIC READING, 3 MAIN ISSUES WERE: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. THE READINGS WERE VERY ERRATIC EAR AND FINGER READING AT LEAST 2 PERCENT DIFFERENT, TRIED NEW PLETH TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS, ALSO BLOOD GAS MONITOR TESTED AGAINST. THE SECOND MODEL WE TRIALED HAD MORE STABLE READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351140 ↗
• MalfunctionAug 31, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE IS SHOWING SERVICE ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327191 ↗
• MalfunctionAug 31, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  10/16 IT WAS REPORTED THAT A TRAIL CARRIED OUT THE FOLLOWING REPORTS OF ERRATIC READING, 3 MAIN ISSUES WERE: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. THE READINGS WERE VERY ERRATIC EAR AND FINGER READING AT LEAST 2% DIFFERENT, TRIED NEW PLETH TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS, ALSO BLOOD GAS MONITOR TESTED AGAINST. THE SECOND MODEL WE TRIALED HAD MORE STABLE READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327186 ↗
• MalfunctionAug 31, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A TRAIL CARRIED OUT THE FOLLOWING REPORTS OF ERRATIC READING, 3 MAIN ISSUES WERE: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. THE READINGS WERE VERY ERRATIC EAR AND FINGER READING AT LEAST 2% DIFFERENT, TRIED NEW PLETH TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS, ALSO BLOOD GAS MONITOR TESTED AGAINST. THE SECOND MODEL WE TRIALED HAD MORE STABLE READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327152 ↗
• MalfunctionAug 31, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  (8/16). IT WAS REPORTED THAT A TRAIL CARRIED OUT FOLLOWING REPORTS OF ERRATIC READING, 3 MAIN ISSUES WERE: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. THE READINGS WERE VERY ERRATIC EAR AND FINGER READING AT LEAST 2% DIFFERENT, TRIED NEW PLETH TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS, ALSO BLOOD GAS MONITOR TESTED AGAINST. THE SECOND MODEL WE TRIALED HAD MORE STABLE READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327112 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SUSPECT DEVICE WAS PROVIDING INCORRECT READING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327089 ↗
• MalfunctionAug 31, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A TRAIL CARRIED OUT FOLLOWING REPORTS OF ERRATIC READING, 3 MAIN ISSUES WERE: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. THE READINGS WERE VERY ERRATIC EAR AND FINGER READING AT LEAST 2% DIFFERENT, TRIED NEW PLETH TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS, ALSO BLOOD GAS MONITOR TESTED AGAINST. THE SECOND MODEL WE TRIALED HAD MORE STABLE READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327084 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SUSPECT DEVICE WAS PROVIDING INCORRECT READING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327063 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WITH USE OF THE DEVICE THE SIZE OF THE EAR PROBE WAS TOO BIG, PROVED DIFFICULT TO POSITION PROPERLY AND THE READINGS WERE VERY ERRATIC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327029 ↗
• MalfunctionAug 31, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A TRAIL CARRIED OUT FOLLOWING REPORTS OF ERRATIC READING, 3 MAIN ISSUES WERE: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. THE READINGS WERE VERY ERRATIC EAR AND FINGER READING AT LEAST 2 PERCENT DIFFERENT, TRIED NEW PLETH TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS, ALSO BLOOD GAS MONITOR TESTED AGAINST. THE SECOND MODEL WE TRIALED HAD MORE STABLE READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327026 ↗
• MalfunctionAug 31, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  (11/16). IT WAS REPORTED THAT A TRAIL CARRIED OUT FOLLOWING REPORTS OF ERRATIC READING, 3 MAIN ISSUES WERE: THE SIZE OF THE EAR PROBE WAS TOO BIG AND PROVED DIFFICULT TO POSITION PROPERLY. THE READINGS WERE VERY ERRATIC EAR AND FINGER READING AT LEAST 2 PERCENT DIFFERENT, TRIED NEW PLETH TO NO AVAIL. SEVERAL DEVICES IN THE COMMUNITY TEAM SAME ISSUE. THE READINGS DID NOT MARRY UP WITH THOSE TAKEN USING THE WARD HIGH DEPENDENCY MONITOR EAR PLETHS, ALSO BLOOD GAS MONITOR TESTED AGAINST. THE SECOND MODEL WE TRIALED HAD MORE STABLE READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327014 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, WITH USE OF THE DEVICE, THE SIZE OF THE EAR PROBE WAS TOO BIG, PROVED DIFFICULT TO POSITION PROPERLY, AND THE READINGS WERE VERY ERRATIC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326859 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, WITH USE OF THE DEVICE, THE SIZE OF THE EAR PROBE WAS TOO BIG, PROVED DIFFICULT TO POSITION PROPERLY, AND THE READINGS WERE VERY ERRATIC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326719 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, WITH USE OF THE DEVICE, THE SIZE OF THE EAR PROBE WAS TOO BIG, PROVED DIFFICULT TO POSITION PROPERLY, AND THE READINGS WERE VERY ERRATIC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326712 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SUSPECT DEVICE WAS PROVIDING INCORRECT READING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326568 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, WITH USE OF THE DEVICE, THE SIZE OF THE EAR PROBE WAS TOO BIG, PROVED DIFFICULT TO POSITION PROPERLY, AND THE READINGS WERE VERY ERRATIC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326428 ↗
• MalfunctionAug 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE HAD AN ERROR 15. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278052 ↗
• MalfunctionAug 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE OXIMETER STOPPED READING. CUSTOMER BELIEVES THIS TO BE DUE TO A FRAYED WIRE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350289 ↗
• MalfunctionAug 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE OXIMETER STOPPED DOING A READOUT. THE CUSTOMER BELIEVES THIS WAS DUE TO A FRAYED WIRE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350049 ↗