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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 Display or Visual Feedback Problem (1184); Pacing Problem (1439)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that the mobile programmer's pacing system analyzer (psa) stopped working while in use on a dependant patient. The analyzer was not responding and presented with an hourglass and a warning. It was noted that the programmer stayed in ventricle output only (voo) mode and could not be switched from this mode. It was further noted that the user was not able to test either lead. The user resorted to using a replacement non-mobile programmer with an analyzer to complete the case. It was speculated that the issue may have been caused due to a telemetry connection issue with the device and patient reader or a bluetooth connection issue with the tablet and the patient reader. The issue has been escalated to find a resolution. 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 Key10566107
MDR Text Key207897078
Report Number3004593495-2020-01104
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/2020
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/21/2019
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: 09/22/2020 Patient Sequence Number: 1
Treatment
24967 PATIENT CONNECTOR
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