MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM MEDIA CONVERTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.

Event Description

Related manufacturer reference: 2184149-2019-00211.During preparation for the procedure, smoking devices were noted.When the stimulator was turned on, the touchscreen was not communicating with the stimulator.The media convertor was checked and was not powered since the power supply was not completed plugged in.When plugging in the cable, the media converter started to smoke.It is unknown which component was the cause of the smoking.There was no patient involved.

Manufacturer Narrative

One workmate¿ media converter was received for evaluation.Inspection of the internal electrical components did not reveal signs of short circuits which could result in the reported event.Functional testing of the returned media converter confirmed normal functionality with no interruptions observed.Based on the information provided to abbott and the investigation performed, the root cause of the reported smoking cannot be conclusively determined as no abnormalities were identified.A review of the device history record was not possible since the batch number is unavailable.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM MEDIA CONVERTER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9283993
• MDR Text Key: 165212595
• Report Number: 2184149-2019-00210
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: WORKMATE¿ SYSTEM POWER SUPPLY