MAUDE Adverse Event Report: ST PAUL BCI SPECTRO2 10 PULSE OXIMETER

Model Number WW1000A1EN

Device Problem Device Alarm System (1012)

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

Event Type  malfunction  

Event Description

It was reported that the device is showing service error.No patient injury was reported.

Manufacturer Narrative

The returned device first time in for service after 6 months in the field and the failure resulted from defective main board no longer detecting spo2 functions.The 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 b10009406, as a result of warning letter cms# 617147.

• Brand Name: BCI SPECTRO2 10 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: 15327191
• MDR Text Key: 305378859
• Report Number: 3012307300-2022-16985
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000283
• UDI-Public: 30843418000283
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083787
• 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: WW1000A1EN
• Device Catalogue Number: WW1000A1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1