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

Model Number 24970A

Device Problems Device Difficult to Program or Calibrate (1496); Computer Operating System Problem (2898)

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

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis confirmed that when creating a portable document format (pdf) in the application and an attempt was made to send it to the universal serial bus (usb), by using "send to", the screen froze.According to the logs, an exception occurred while reopening the socket when the application came to the foreground.This is a known background foreground issue what was fixed with a new version.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was further reported that the programmers screen had froze when saving the pdf to the usb in the mobile programmer application.After that, the application was rebooted, but the same event occurred twice.The pdf could be saved the third time.

Manufacturer Narrative

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

Event Description

It was reported that there was incorrect programming/programming difficulty with the programmer.It was noted that the programmer screen froze by storing portable document format (pdf) in the universal serial bus (usb) memory stick when the mobile programmer application was run.The issue was attempted to be resolved by shutting down and rebooting the application, however the same event occurred twice.The issue was noted to resolve with a reboot.The programmer remains in use.No patient complications have been reported as a result of this event.

• 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: 9538674
• MDR Text Key: 175553796
• Report Number: 3004593495-2020-00004
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P890003
• 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,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• 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?: Yes
• Date Manufacturer Received: 01/15/2020
• 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