MAUDE Adverse Event Report: ST PAUL BCI SPECTRO2 30 PULSE OXIMETER

Model Number WW1030EN

Device Problem No Visual Prompts/Feedback (4021)

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

Event Type  malfunction  

Event Description

It was reported that the light does not flash.No patient injury was reported.

Manufacturer Narrative

A product sample was received for evaluation.Visual and functional testing were performed.The product was received in good condition.The reported problem was unconfirmed, however it was that the monitor was non-functional with the keypad; it was unresponsive and the oximeter board was faulty, not communicating with the main board.The root cause of the reported problem was unable to be determined.The device history record (dhr) review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI SPECTRO2 30 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; minneapolis, MN 55442
• MDR Report Key: 15327038
• MDR Text Key: 305418050
• Report Number: 3012307300-2022-16968
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WW1030EN
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1