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

Catalog Number WW1030DE

Device Problem Defective Alarm (1014)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Visual and functional testing were performed.The device looked to be in new condition, no cracks or damage visible.Functional testing duplicated the reported problem.The root cause of the reported issue was found to be a cracked light-emitting diode (led) caused by plastic light too close to red led.The led was replaced.The device history record (dhr) review was 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.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

Event Description

It was reported that the device red light-emitting diode (led) alarm was not working.No patient injury was reported.

• 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: 15322836
• MDR Text Key: 305357429
• Report Number: 3012307300-2022-16847
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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 Catalogue Number: WW1030DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1