MAUDE Adverse Event Report: ST PAUL BCI WW1030 PULSE OXIMETER

Model Number WW1030P1EN

Device Problems Defective Alarm (1014); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was not performed because 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 but the red light-emitting diode (led) was damaged from impact.The reported problem was duplicated.The monitor was powered up and the red led did not light up.The main board was replaced.The root cause of the reported issue was found to be impact to the monitor.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the light on top of the device will not work when alarming.No patient injury was reported.

• Brand Name: BCI WW1030 PULSE OXIMETER
• Type of Device: 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; 3223 32nd ave s; minneapolis, MN 55442
• MDR Report Key: 15321541
• MDR Text Key: 305086673
• Report Number: 3012307300-2022-16792
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418001211
• UDI-Public: 30843418001211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WW1030P1EN
• Device Catalogue Number: WW1030P1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1