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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 Computer Software Problem (1112); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2017
Event Type  Malfunction  
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 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.

 
Manufacturer Narrative

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

 
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.

 
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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 Key6781105
MDR Text Key82489323
Report Number3004593495-2017-00423
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,Followup
Report Date 12/07/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/22/2017
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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