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U.S. Department of Health and Human Services

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

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PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Sensing Problem (2917); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event 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.

 
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.

 
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Brand NameCARELINK SMARTSYNC
Type of DeviceANALYZER, 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 Key7103356
MDR Text Key94566277
Report Number3004593495-2017-00787
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24970A
Device Catalogue Number24970A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/28/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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