MAUDE Adverse Event Report: ST PAUL BCI SPECTRO2 30 PULSE OXIMETER OPTIONAL ACCESSORIE

Model Number	WW3078
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ear probe was not reading the signal.No patient injury was reported.
Additional Manufacturer Narrative
The reported problem could not be confirmed and this item is a distributed purchased finished good (pfg) not manufactured by smiths-medical; therefore, the dhr review is not applicable.The device was returned for evaluation.Visual and functional testing were performed.Visual inspection found no physical damage.Functional testing found the sensor probe was tested on a live patient using a good known test monitor and the probe was reading properly.The base was manipulated on both ends and no fault found during the test.The sensor probe was working properly.No problem found.The condition of the sensor probe is still in good physical condition.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: BCI SPECTRO2 30 PULSE OXIMETER OPTIONAL ACCESSORIE
• 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: 15320700
• Report Number: 3012307300-2022-16749
• Device Sequence Number: 5517959
• Product Code: DQA
• UDI-Device Identifier: 30843418001099
• UDI-Public: 30843418001099
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K020739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• 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
• Operator of Device: Other
• Device Model Number: WW3078
• Device Catalogue Number: WW3078
• Device Lot Number: 1942-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown