• 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 PULSE-GENERATOR, PACEMAKER, EXTERNAL

  • 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 PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5392
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 11/08/2018
Event Type  Malfunction  
Manufacturer Narrative

It was confirmed that the knob was missing. The knob's encoder was pushed into the device housing. The epg failed a functional test related to pacing rate. A capacitor was found to be damaged. The case and hanger were found to be damaged. All found defective parts were replaced and all other identified issues were resolved. The device was re-calibrated and functionally tested and it passed its final quality assurance tests. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the external pulse generator (epg) was missing a knob. The epg was returned for service. There was no patient i nvolvement. The epg tested out of specification, during analysis.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DevicePULSE-GENERATOR, PACEMAKER, EXTERNAL
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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8176287
MDR Text Key130791477
Report Number3004593495-2018-01173
Device Sequence Number1
Product Code DTE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5392
Device Catalogue Number5392
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/31/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-