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

Model Number	24970A
Medical Device Problem Codes	Computer Software Problem (1112); Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported there was an excessive lag in tap to action time with the mobile programmer application and some "crashes" were experienced.Also, two new batteries were installed, but a serious battery issue message was received which prevented the analyzer from launching.After "killing" the application twice, disconnecting the testing cables, "killing" it again and restarting, it worked.However, during testing later, it crashed again and continued to get a serious error message with an analyzer electrical reset.It was further noted that there were issues with printing.Hitting "return" froze the keyboard and pressing "view" before selecting the report opened the previous report.The mobile programmer application was abandoned and another programmer/analyzer model was used.The mobile programmer application remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Eval code-conclusion.The reported out of specification issues with the mobile programmer application of the application crashing, error messages being displayed, the keyboard "freezing," and printing problems were confirmed.The power source issues could not be confirmed because the base unit was not returned.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: 6781105
• Report Number: 3004593495-2017-00423
• Device Sequence Number: 969470
• Product Code: DTC
• UDI-Device Identifier: 00643169868540
• UDI-Public: 00643169868540
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2017

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: 06/02/2017
• Supplement Date Received by Manufacturer: 10/23/2017; 10/11/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 11/09/2017; 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1