MAUDE Adverse Event Report: ST PAUL BCI SPECTRO 10 PULSE OXIMETER

Model Number	WW1000EN
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was its first time in for service after 1 year in the field and the reported could not be confirmed but suspected the customer's concern is part of normal operation of the monitor plus evidence of housing damage were present.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.Device manufactured in 2019.D5 is unknown.No information provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the device is displaying error message "service error".No patient injury was reported.

• Brand Name: BCI SPECTRO 10 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: 15335386
• Report Number: 3012307300-2022-17241
• Device Sequence Number: 20442704
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: 30843418000016
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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: WW1000EN
• Device Catalogue Number: WW1000EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2019
• 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