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

Model Number 24970A

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896); Computer Operating System Problem (2898)

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

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis : analysis confirmed original complaint.The behavior is linked to a known issue, rpi 108712.The interrogation hangs when initiated while the application is in background.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during use of an electrocautery device, the programmer had been placed on the cart next to the cautery machine.When the physician started using cautery, the programmer displayed a dotted line for the connection status.When cautery was turned off, the connection resumed.When the physician continued use of cautery, the application completely crashed and the home screen was displayed.In addition, when first pulling up the programmer, and trying to pair the patient connector, the application completely froze.A spinning hour glass displayed, and the application was frozen for five minutes.The user closed the application to restart.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: 9629918
• MDR Text Key: 176381295
• Report Number: 3004593495-2020-00061
• Device Sequence Number: 1
• Product Code: DTC
• UDI-Device Identifier: 00643169957657
• UDI-Public: 00643169957657
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• 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