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

Model Number	WW3078
Medical Device Problem Code	Intermittent Capture (1080)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This item is a distributed purchased finished good (pfg) that is manufactured by another company; therefore the dhr is not available for review.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found device condition to be poor; the base near the male pins have physical damage.Functional testing found the cord of the probe and still would not read; performed continuity test on the probe and found the orange and black wire open.The probe is defective and will not read.The root cause of the reported issue was found to be user interface; the open wires resulted from poor strain relief at the device connection end due to cord being subject to heavy use with extraneous forces.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the oximeter is not reading correctly, the cord had to be maneuvered to get the red light to turn on.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: 15320808
• Report Number: 3012307300-2022-16760
• Device Sequence Number: 5203233
• Product Code: DQA
• UDI-Device Identifier: 30843418001099
• UDI-Public: 30843418001099
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K020739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: Health Professional
• Device Model Number: WW3078
• Device Catalogue Number: WW3078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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