MAUDE Adverse Event Report: ST PAUL BCI WW1000 PULSE OXIMETER

Model Number	WW1000A1EN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Visual and functional testing were performed.The device was in good condition and no damages or defects were noted.Functional testing found the values were valid, no difference found, and readings were stable as expected.The root cause of the issue could not be determined because the device was not tested using the ear probe that the customer was concerned about.However, the reported issue is a known failure isolated to the use of these ear probes with the monitor.Previous investigation of the same issue on prior complaints confirmed the ear probes to be malfunctioning and causing erratic readings but the device was operating as intended when spo2 probes other than ear probes are used.A device history record (dhr) review is not applicable in this case because the defective ear probe manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
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.

• Brand Name: BCI WW1000 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15326428
• Report Number: 3012307300-2022-16902
• Device Sequence Number: 5288066
• Product Code: DQA
• UDI-Device Identifier: 30843418000283
• UDI-Public: 30843418000283
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WW1000A1EN
• Device Catalogue Number: WW1000A1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown