MAUDE Adverse Event Report: ST PAUL BCI SPECTRO2 PULSE OXIMETER

Model Number 3301A1

Device Problem Device Alarm System (1012)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

The returned device first time in for service after 8 years in the field and the failure resulted from malfunctioning main board.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.Operator of device and initial reporter also sent to fda?: are unknown.No information provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device is presenting with an error.No patient injury was reported.

• Brand Name: BCI SPECTRO2 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: 15327077
• MDR Text Key: 305277310
• Report Number: 3012307300-2022-16977
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000849
• UDI-Public: 30843418000849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943404
• 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: 08/31/2022

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 Model Number: 3301A1
• Device Catalogue Number: 3301A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1