MAUDE Adverse Event Report: ST PAUL BCI OXIMETER SPECTRO2

Model Number	WW1030EN
Medical Device Problem Codes	Device Alarm System (1012); Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3012307300-2023-05454
• Device Sequence Number: 20528597
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown