MAUDE Adverse Event Report: ST PAUL BCI OXIMETER SPECTRO2

Model Number WW1030EN

Device Problems Device Alarm System (1012); Erratic or Intermittent Display (1182)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(6).A product sample was received for evaluation.Visual and functional testing were performed.There is no physical damage on the device.The reported complaint was not verified after test.The returned device and no error was found.A live patient was tested with a good known probe and was able to take readings.The alarming was within specification and set at the default settings.The keypad worked as intended no damaged was found.The device never rebooted or shown error message.The root cause of the reported issue was not able to be determined.Actions were taken to mitigate the reported issue: none.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

Event Description

It was reported, that the device was alarming intermittenly.Repeat power up, keypad fail, and show error message.No patient injury was reported.

• Brand Name: BCI OXIMETER SPECTRO2
• Type of Device: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16901604
• MDR Text Key: 314893583
• Report Number: 3012307300-2023-05454
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/10/2023

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: Health Professional
• Device Model Number: WW1030EN
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1