MAUDE Adverse Event Report: ST PAUL BCI WW1030 PULSE OXIMETER

Model Number	WW1030P1EN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is giving inaccurate readings.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was not performed because it would not be applicable or relevant as the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.The device was returned for evaluation.Visual and functional tests were performed.The device was received in good physical condition.The reported problem was not duplicated.The monitor tested and read accurately within range of simulated values.The customer did not send in their probe so a complete investigation could not be performed.The root cause of the reported problem could not be determined.This remediation mdr was generated under protocol (b)(4), 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: 15320890
• Report Number: 3012307300-2022-16772
• Device Sequence Number: 5206336
• Product Code: DQA
• UDI-Device Identifier: 30843418001211
• UDI-Public: 30843418001211
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Operator of Device: Health Professional
• Device Model Number: WW1030P1EN
• Device Catalogue Number: WW1030P1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2018
• 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