MAUDE Adverse Event Report: ST PAUL BCI OXIMETER SPECTRO2

Model Number	WW1020EN
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a smiths medical oximeter is coming up with sr error when plugged in and is not lighting up.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.However found residues on the main board suspected to be unclean soldering flux or contaminant around the u15 chip and the main board has been replaced as precaution.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.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10455.The report was submitted in error.

• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; industrial estate; minneapolis, MN 55442
• MDR Report Key: 12808037
• Report Number: 3012307300-2021-10455
• Device Sequence Number: 19999014
• Product Code: DQA
• UDI-Device Identifier: 30843418000108
• UDI-Public: 30843418000108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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: WW1020EN
• Device Catalogue Number: WW1020EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/09/2022; 05/03/2023
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 03/10/2022; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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