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

Model Number WW1030P1EN

Device Problems Fire (1245); Power Problem (3010); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event 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.

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)
• 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; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8746932
• MDR Text Key: 149609842
• Report Number: 3012307300-2019-02962
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• 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: 06/18/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/30/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1