DUAL CHAMBER TEMPORARY PACEMAKER 5392

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-23 for DUAL CHAMBER TEMPORARY PACEMAKER 5392 manufactured by Plexus Manufacturing Sdn. Bhd.

Event Text Entries

[184637830] Product analysis: analysis was able to confirm the customer comment that the external pulse generator (epg) displayed an error message which was found to have occurred multiple times. It was further noted during analysis that the main printed circuit board (pcb), upper case, keyboard flex, encoder knob, lower case, display, display frame, four display grommets, insulator label and two main pcb screws were contaminated. It was further noted that the hanger assembly was broken. All found defective parts were replaced and all other identified issues were resolved with firmware updated and the epg passed all final functional tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184637831] It was reported that the external pulse generator (epg) displayed an error message. The epg was received into service and repair. No patient complications have been reported as a result of this event. It was further reported that the epg subsequently failed functional testing during manufacturer's analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004593495-2020-00310
MDR Report Key9869179
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-20
Date Mfgr Received2020-03-11
Device Manufacturer Date2018-12-22
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1PLEXUS MANUFACTURING SDN. BHD
Manufacturer StreetBAYAN LEPAS FREE INDUSTRIAL ZO
Manufacturer CityBAYAN LEPAS 11900
Manufacturer CountryMY
Manufacturer Postal Code11900
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDUAL CHAMBER TEMPORARY PACEMAKER
Generic NamePULSE-GENERATOR, PACEMAKER, EXTERNAL
Product CodeDTE
Date Received2020-03-23
Returned To Mfg2020-02-24
Model Number5392
Catalog Number5392
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPLEXUS MANUFACTURING SDN. BHD
Manufacturer AddressBAYAN LEPAS FREE INDUSTRIAL ZO BAYAN LEPAS 11900 MY 11900


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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