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

Model Number	24970A
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Sensing Problem (2917); Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 7103356
• Report Number: 3004593495-2017-00787
• Device Sequence Number: 13846614
• Product Code: DTC
• UDI-Device Identifier: 00643169868540
• UDI-Public: 00643169868540
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K163008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 12/10/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1