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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 Problems Pacing Problem (1439); Capturing Problem (2891); Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Output Problem (3005)
Patient Problem Cardiac Arrest (1762)
Event Date 01/30/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that during an implant procedure, the mobile programmer ¿¿froze¿¿ and a sudden loss of connectivity between the programmer base and tablet was experienced. The user reports that the analyzer screen was open but unable to provide electrograms (egm) or live information. The user also reports the patient experienced asystole along with a loss of capture at rates of 60 beats per minute (bpm) and was able to capture rates of 70 bpm and above. An alternative programmer was then used to complete the procedure with no issues with pacing or maintaining capture reported. The programmer remains in use. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

The analysis of the device logs was able to confirm the disconnection between the programmer base and associated tablet. The base was disconnected, without any visible reason (no restart of the programmer base according to the device logs and no base tablet noise reported). The main graphical user interface thread also stopped sending the safety ping requests (as there are evidence of the safety ping timeouts in the logs) without any logged entry the app was going to the background. This may be potential evidence of the observed ''application freeze''. The patient connector was connected via the universal serial bus (usb) cable through the programmer base at the time of the event. It appears the tablet returned to activities approximately 10 seconds later, resuming the base tablet connection back including the telemetry session. It is not clear why the base tablet connection was closed, the reason may be due to the fact the application (or whole tablet) froze for a period, which in turn caused the base tablet supervision timeout, leading to the connection loss. If information is provided in the future, a supplemental report will be issued.

 
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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 Key9746292
MDR Text Key180621491
Report Number3004593495-2020-00183
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24970A
Device Catalogue Number24970A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/22/2019
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: 02/24/2020 Patient Sequence Number: 1
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