MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE; PROGRAMMER, PACEMAKER

Model Number 29901

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis confirmed the reported issue; there was a melted power connector on the programmer and the power supply.The device powered up and interrogated on battery power.Due to a lack of replacement parts being available, the programmer was scrapped.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer was smoking at the charging port while plugged in to a power outlet.The programmer was unplugged and the smoking stopped.It was noted that there were burn marks and melted plastic at the charging port and the tip of the charging cord.The programmer has been returned for service.There was no patient involvement.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Failure analysis was performed on the power supply.Visual inspection: power connector has melted plastic around the metal plug.Benchtop analysis: checked electrically connection between the output and the ground ¿ electrical short.Conclusion: confirmed customer complaint caused by power supply connector failure.The dc plug cable end is electrically shorted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK ENCORE
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7723549
• MDR Text Key: 115391474
• Report Number: 3004593495-2018-00696
• Device Sequence Number: 0
• Product Code: KRG
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29901
• Device Catalogue Number: 29901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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