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

Model Number 24970A

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Sensing Problem (2917); Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2017

Event Type  Malfunction  

Manufacturer Narrative

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

Event Description

It was reported the user could not assess the leads during the case. Upon attempting to analyze the first lead (atrial), the tablet showed dotted lines all along the egm (electrogram) baseline. It was further noted there was an error message, and question marks showed in many of the parameter fields. The user could not operate the application at this point, and a force close and reboot of the application appeared to have worked, but it was too late into the case to do this and successfully complete the case, so a legacy analyzer was used to complete the case. The mobile programmer application remains in use. No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the reported out of specification issue with the mobile programmer application was confirmed. If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK SMARTSYNC
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7103356
• MDR Text Key: 94566277
• Report Number: 3004593495-2017-00787
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K163008
• 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: 02/08/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/10/2017
• 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?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/28/2017
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse