MAUDE Adverse Event Report: ST PAUL SPECTRO2 30 PULSE OXIMETER

Model Number	WW1030EN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received for evaluation.Visual and functional testing were performed.The device was received in good condition.Functional testing self-test passed, no error messages.Unit ran for a couple of minutes with sensor attached and readings, then it switched off and on randomly.The root cause was identified to be related to the supplier of the main board for the device.Faulty mainboard was replaced.A 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.Operator of device is unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported the machine was reading continuously without stopping.No patient injury was reported.

• Brand Name: SPECTRO2 30 PULSE OXIMETER
• Common Device Name: 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: 15320195
• Report Number: 3012307300-2022-16706
• Device Sequence Number: 14829051
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K083557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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 Model Number: WW1030EN
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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