MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 3650

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2020

Event Type  malfunction  

Event Description

It was reported the merlin programmer was turned on but a short circuit resulting in sparks occurred.The product was not switched on again and was unable to be used.No patient was involved.

Manufacturer Narrative

The visual inspection revealed no physician damage to the unit.The programmer exhibited normal visual characteristics.The programmer was plugged in to an external power source and powered on, but the screen was very dark.The power up anomaly was verified as the event could be reproduced.The reported event of short circuit resulting in sparks was not reproduced.Troubleshooting revealed a defective tft backlight inverter as the root-cause for this issue and was resolved by replacing the tft backlight inverter.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10471196
• MDR Text Key: 204912942
• Report Number: 2017865-2020-12519
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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: Health Professional
• Device Model Number: 3650
• Device Catalogue Number: 3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1