MAUDE Adverse Event Report: ST PAUL BCI OXIMETER SPECTRO2 - WW1000 SERIES

Model Number WW1000EN

Device Problem Computer Software Problem (1112)

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

Event Type  malfunction  

Event Description

It was reported that there was a po22 code.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

No information has been provided to date.The 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.Device manufactured in 2012.Monitor powered up properly to home screen and passed spo2 simulation test without fault.However, determined that the customer's returned spo2 probe was at fault.

• Brand Name: BCI OXIMETER SPECTRO2 - WW1000 SERIES
• Type of Device: 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: 15600902
• MDR Text Key: 306793522
• Report Number: 3012307300-2022-23921
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: 30843418000016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WW1000EN
• Device Catalogue Number: WW1000EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1