MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI OXIMETER SPECTRO2 - WW1000 SERIES

Model Number WW1030P1EN

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: one bci monitor device was received for investigation in good condition with a red boot and chargeable battery.The red led light was inspected on the main board and it was found to have one end of the led broken off the board due to impact.The main board was replaced and now the red led light is present on device power up.Based on the investigation and testing, the complaint was confirmed.The display issue was noted to be a result of impact sustained by the monitor during use and handling.The evaluation noted that the operation manual informs the user (chapter 1) in the warning section with the following information: "any monitor that has been dropped or damaged, should be inspected by qualified service personnel, prior to use, to insure proper operation.".

Event Description

Information was received that a smiths medical bci oximeter spectro2 - ww1000 series top alarm light was not working.The reporter declined to provide any further information.

• Brand Name: BCI OXIMETER SPECTRO2 - WW1000 SERIES
• Type of Device: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9377144
• MDR Text Key: 168225778
• Report Number: 3012307300-2019-06655
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418001211
• UDI-Public: 30843418001211
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW1030P1EN
• Device Catalogue Number: WW1030P1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1