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U.S. Department of Health and Human Services

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

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PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC BASE ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2020
Event Type  Malfunction  
Manufacturer Narrative

Product event summary:the device was not returned for analysis. However performance data collected from the device was received and analysed. Analysis of the device memory was performed and indicated a certificate renewal failure issue was experienced which was a known issue. The software of the mobile programmer was updated to latest version which resolved the issue. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the mobile programmer lost connection with the patient connector. The user removed the patient connector 3 inches which caused the mobile programmer application to indicate that it lost connection, followed by the tablet going red and it could not interrogate. It was noted that the tablet was 2 inches from the patient and that the patient was totally dependant. It was further noted that the user had wireless fidelity (wifi) turned off and that the user attempted to reconnect to the patient connector but the implantable device serial number would not pop up as an available patient connector to select. The user can usually swipe the mobile programmer application closed and restart it to resolve the issue, but on this occasion the user was pressed on time and used an alternative programmer instead. The issue was escalated to find a resolution for the user and has been resolved. No patient complications have been reported as a result of this event.

 
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Brand NameCARELINK SMARTSYNC BASE
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10552831
MDR Text Key207519944
Report Number3004593495-2020-01082
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP890003
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 10/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/23/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/18/2020 Patient Sequence Number: 1
Treatment
24967 PATIENT CONNECTOR
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