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

Model Number	WW1030P1EN
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9377144
• Report Number: 3012307300-2019-06655
• Device Sequence Number: 16904132
• Product Code: DQA
• UDI-Device Identifier: 30843418001211
• UDI-Public: 30843418001211
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1