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

Model Number 24970A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  Malfunction  

Manufacturer Narrative

Product analysis: analysis of the device logs were able to confirm the customer comments that a loss in connection was encountered during analyzation. The event is related to a known issue related to random but high frequency of waveform dots due to wireless fidelity and the operating system. If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the mobile programmer encountered a loss of connection between the tablet, base and patient connector during use of the analyzer. The issue occurred following an update to the application. The device 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: 10331277
• MDR Text Key: 200607520
• Report Number: 3004593495-2020-00787
• 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: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/28/2020
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2020
• 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