MAUDE Adverse Event Report: ST PAUL BCI WW1030 PULSE OXIMETER

Model Number	WW1030EN
Medical Device Problem Code	Low Audible Alarm (1016)
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 device had a very quiet alarm.No patient injury was reported.
Additional Manufacturer Narrative
A device history report (dhr) review is not relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.The product was returned for evaluation.Visual inspection revealed a cracked screw insert.Functional testing duplicated the reported problem.The root cause of the reported issue was found to be malfunctioning speaker from fluid ingression.The speaker was replaced.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

• Brand Name: BCI WW1030 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16632709
• Report Number: 3012307300-2023-03151
• Device Sequence Number: 7150066
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K083557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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: WW1030EN
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2022
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2016
• 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