MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. BCI ADVISOR VITAL SIGNS MONITOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number V9200

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that during use of the listed device, a burning smell was noticed coming from the monitor.The monitor appeared to be working properly prior to smell.No adverse health outcome resulted from this event.

Manufacturer Narrative

Customer complaint regarding the monitor smoking was verified.The returned monitor v9200 s/n (b)(4) (dom: oct-2013) powered up during evaluation with com error displayed in the parameter box.Technician opened the monitor and noted that the u30, u31 and u32 chips which are 8-bit addressable latch/1 of 8 decoders interfacing the microcomputer u28 with the i/o signals in the dsp (digital signal processing) module schematic on the main board burned out including the u29 chip which is an octal buffer/driver with 3 state output connecting the same microcomputer.Further analysis determined that a faulty voltage regulator u56 in the power circuitry that powers the microcomputer u28 with a regulated 3.3v, 250 ma was faulty.The required input voltage of 5 v was detected but the output voltage showed near 0v instead of 3.3v indicating a component breakdown.Ultimately the 2nde voltage regulator u18 powering the core of the dsp with 1.8 v, 100 ma was inactive as input and output voltage measured 0v, since its input voltage is provided by 3.3 v regulator previously found defective.As result, the microcomputer u28 had no power to operate with resulting in malfunction.In addition, according to electrical characteristics of both regulators (lp2992im5 and tps79118dbv) they drive high output current with low output voltage which consequently caused the microcomputer to send an out of range high current through the i/o decoders and caused them to burn.What caused the regulator u56 to go bad in the first place could not be determined as the power supply circuitry was tested and found to be delivering the expected voltage level.There were no sign of external power surge or fluid entry and the protective fuses were not altered.The customer reported that the monitor was powered through a surge protector strip at the time the problem occurred.

• Brand Name: BCI ADVISOR VITAL SIGNS MONITOR
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5262025
• MDR Text Key: 32561883
• Report Number: 2183502-2015-00928
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030407
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V9200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2013
• 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