MAUDE Adverse Event Report: ST PAUL BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR; OXIMETER

Model Number	WW3078
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Visual and functional testing were performed.The device was in good condition and there were no physical damage or defects.The reported erratic reading was confirmed and isolated to the ear probes.The returned oximeter was found to be operating as intended and acquired readings accurately within specifications when tested on a 4086 multiparameter simulator and when finger sensors were used.Malfunctioning ear probes was a result of detector sensitivity to noises and causing erratic readings.The root cause of the reported issue was found to be a supplier issue.Additional information has been requested from the supplier.A device history record (dhr) review is not applicable because the manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
Event or Problem Description
It was reported that fluctuations were noted while using the ear sensor.Another sensor was used and it worked fine.No patient injury was reported.

• Brand Name: BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
• 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: 15326883
• Report Number: 3012307300-2022-16950
• Device Sequence Number: 12340829
• Product Code: DQA
• UDI-Device Identifier: 30843418001099
• UDI-Public: 30843418001099
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K020739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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: 1952-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• 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: 05/20/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2020
• 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