MAUDE Adverse Event Report: ST PAUL BCI WW1030 PULSE OXIMETER

Model Number	WW1030EN
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an incorrect reading issue with the reported device.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device or prior repair of the device.A product sample was received for evaluation.Visual inspection and functional testing were performed.The main board was observed to be physically damaged.The monitor was tested with a simulator and all readings were accurate.A known good finger probe was used, and the readings would go in and out.During functional testing, the technician was able to duplicate the reported issue of incorrect data.Replaced the spo2 board and main board to resolve the reported issue.All readings were accurate and steady with a simulator and known good probe.The root cause of the reported issue was found to be a faulty spo2 board.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: BCI WW1030 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: 15322719
• Report Number: 3012307300-2022-16842
• Device Sequence Number: 12063036
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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
• Device Model Number: WW1030EN
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2010
• 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