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,foreig report with the FDA on 2020-03-31 for DUAL CHAMBER TEMPORARY PACEMAKER 5392 manufactured by Plexus Manufacturing Sdn. Bhd.

Event Text Entries

[185991240] Product analysis: analysis was able to confirm that an error code was encountered on the external pulse generator (epg). Analysis also noted that the main printed circuit board (pcb) was contaminated and failed the incoming functional ventricular pace pulse noise test, the hanger assembly was broken, the upper case was contaminated, the keypad was contaminated, the lower case was broken, the main seal was contaminated, the display was contaminated, the display frame and two display grommets were contaminated, two case screws were contaminated, two main pcb screws were contaminated, and multiple errors were found in the logs. All found defective parts were replaced and all other identified issues were resolved. The device 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


[185991241] It was reported that an error code was encountered on the external pulse generator (epg). The epg was returned for service. There was no patient involvement. It was further reported that the epg subsequently tested out of specification during manufacturer's analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004593495-2020-00368
MDR Report Key9908214
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-18
Date Mfgr Received2020-03-18
Device Manufacturer Date2016-11-21
Date Added to Maude2020-03-31
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 Received2020-03-31
Returned To Mfg2020-02-13
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 2020-03-31

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