MAUDE Adverse Event Report: ST PAUL BCI; OXIMETER

Model Number WW1030EN

Device Problems Device Alarm System (1012); Self-Activation or Keying (1557)

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

Event Date 06/25/2021

Event Type  malfunction  

Event Description

Information received a smiths medical patient monitoring|bci oximeter spectro2 - ww1000 series malfunctioned.Reported oximeter has been returned by our customer due to a fault with the keypad.The complaint stated intermittent operation of keypad prevented alarms being adjusted or paused.The on/off button ,also reported to be faulty as sometimes the message "clr" flashed during power up; as though the button was being held in permanently when it wasn't being touched at all.Monitor was reported tested by customer and was observed the same intermittent fault.Sometimes reported it would work correctly, other times the above faults would occur.

Manufacturer Narrative

Other, other text: one unit was returned for investigation, upon inspection, it was found that the mainboard was faulty.Root cause was traced to the supplier.Dhr review not done due to issue being traced to supplier.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-08216.The report was submitted in error.

• Brand Name: BCI
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12294127
• MDR Text Key: 265594289
• Report Number: 3012307300-2021-08216
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2023

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
• Device Model Number: WW1030EN
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 09/20/2021; 05/04/2023
• Supplement Dates FDA Received: 10/20/2021; 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1