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

Model Number 24970A

Device Problem Computer Operating System Problem (2898)

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

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the programmer was freezing up during use.The programmer was returned for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: manufacturer's analysis confirmed the customer comment that the programmer was freezing up during use.It appeared that the base station analyzer die-stack experienced a power on reset that caused an analyzer electrical reset error.Use conditions were identified that are known to cause this issue.It was likely the unit experienced a power on reset, due to electrocautery while the base was sitting on a metal surface.The prorgrammer was returned to service.

Manufacturer Narrative

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

• Brand Name: CARELINK SMARTSYNC
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6920270
• MDR Text Key: 88444601
• Report Number: 3004593495-2017-00520
• Device Sequence Number: 1
• Product Code: DTC
• UDI-Device Identifier: 00643169868540
• UDI-Public: 00643169868540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2018

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
• Device Operator: Health Professional
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 10/30/2017; 04/09/2018
• Supplement Dates FDA Received: 12/07/2017; 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2017
• 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