MAUDE Adverse Event Report: ST PAUL BCI OXIMETER AUTO CORR

Model Number 3304

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review is not relevant due to the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.The device was received for evaluation.Visual and functional testing were performed.There is no physical damage on the device.The reported problem was not confirmed.The reported issue could not be confirmed.Initial reporter is unknown.No information has been 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 hade an error code and would not turn on.No patient injury was reported.

• Brand Name: BCI OXIMETER AUTO CORR
• 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: 15397561
• MDR Text Key: 305611518
• Report Number: 3012307300-2022-18485
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10610586036347
• UDI-Public: 10610586036347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070732
• 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: 09/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3304
• Device Catalogue Number: 3304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 09/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1