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

Model Number 6004006

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 presented with an error code.No patient injury was reported.

Manufacturer Narrative

The device was returned for evaluation.The customer stated problem of error code 22, was verified.The monitor was powered up and the error 22 was present on power up.The coin battery was replaced and factory calibration was performed and the error is no longer present.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.Device manufactured in 2014.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: BCI SPECTRO2 30 PULSE OXIMETER
• Type of Device: PATIENT MONITORING
• 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: 15326691
• MDR Text Key: 305384225
• Report Number: 3012307300-2022-16927
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10610586036606
• UDI-Public: 10610586036606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• 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: 6004006
• Device Catalogue Number: 6004006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• 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