MAUDE Adverse Event Report: ST PAUL BCI WW1030 PULSE OXIMETER

Model Number WW1030EN

Device Problem Defective Alarm (1014)

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

Event Type  malfunction  

Event Description

It was reported that the device is alarming and reading low o2 when another unit was reading normally with the same patient.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device in good condition.Error was found in the device ehl (event history log) multiple times.The customer stated problem was not duplicated.The monitor was powered up properly without alarm; however, when the on/off button was pressed it would not turn off.The only way to turn it off is to remover the main battery.Replaced the main board and the device powered up and turned off correctly.The main board power circuitry was shorting and it was replaced.The cause of the reported problem could not be determined.A dhr (device history review) was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during investigation.Service history review identified this device has not been in for service previously., corrected data: d5: correction: operator of the device: unknown.

• Brand Name: BCI WW1030 PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15536716
• MDR Text Key: 306508718
• Report Number: 3012307300-2022-20720
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WW1030EN
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1