MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC BCI OXIMETER(SPECTRO2)

Model Number	WW1030P1EN
Medical Device Problem Codes	Fire (1245); Power Problem (3010); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bci oximeter (spectro2) no longer worked with aa batteries or a power cord.The ac power cord also caught fire.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation : one monitor was received for investigation with fluid contamination visible on the charging port and upon immediate inspection it was visible inside the monitor, all over the main board.The contaminated main board and port found confirms the reported complaint.This failure resulted from fluid ingression.The monitor was returned without the referenced ac power cord in the complaint statement for confirmation and there were no indication of burn or smoke smell inside or on the returned monitor.However, fluid contamination inside the charging connectors would cause the power supply connector pins to short and burn.The event problem source was noted as user interface, with the product being used in a manner inconsistent with the device's ifu.Per the device operation manual (chapter 12): "do not allow water, isopropyl alcohol or any other liquid to enter any of the openings on the monitor.Unplug the ac power cord from the monitor before cleaning or disinfecting.Where the equipment has accidentally gotten wet, it should be wiped dry externally and allowed to dry thoroughly before use.".

• Brand Name: BCI OXIMETER(SPECTRO2)
• Common Device Name: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8746932
• Report Number: 3012307300-2019-02962
• Device Sequence Number: 1926108
• Product Code: DQA
• UDI-Device Identifier: 30843418001211
• UDI-Public: 30843418001211
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 10/11/2019

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: 06/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 06/30/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1