MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC BASE ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number 24970A

Device Problem Computer Software Problem (1112)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2020

Event Type  Malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the when the user switched to pacing on the analyzer to test threshold, the application crashed and displayed a white screen. The programmer remains in use. There was no patient involvement.

• Brand Name: CARELINK SMARTSYNC BASE
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10003048
• MDR Text Key: 189153282
• Report Number: 3004593495-2020-00477
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (Y/N): N
• 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

• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/27/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 09/20/2019
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse