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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 Capturing Problem (2891); Communication or Transmission Problem (2896); Unexpected Shutdown (4019)
Patient Problem No Patient Involvement (2645)
Event Date 09/16/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the programmer base and tablet operating system lost connection during threshold test. The system shut down with a white screen. The patient header was unable to connect. The system shut down when attempting to start up programmer. The programmer remains in use. There was no patient involvement.

 
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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 Key10566709
MDR Text Key207921188
Report Number3004593495-2020-01106
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/20/2020
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? 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 Received09/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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 RADIOFREQUENCY HEAD
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