• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC BASE ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problems Pacing Problem (1439); Communication or Transmission Problem (2896)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2020
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 mobile programmer encountered a loss of communication between the application and patient connector. It was also reported that the analyzer failed to launch. It was noted that the application was recently updated. The device remains in use. No patient complications have been reported as a result of this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10337237
MDR Text Key200816498
Report Number3004593495-2020-00797
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer10/27/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2018
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: 07/29/2020 Patient Sequence Number: 1
Treatment
24967 RADIO FREQUENCY HEAD
-
-