TEMPORARY EXTERNAL PACEMAKER 53401

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-26 for TEMPORARY EXTERNAL PACEMAKER 53401 manufactured by Plexus Manufacturing Sdn. Bhd.

Event Text Entries

[185253972] Product analysis: analysis was able to confirm that the patient output connector on the external pulse generator (epg) was cracked. Incoming tests were unable to be performed because the broken connector was loose from the inside housing. A new patient cable was placed but the device did not pass multiple final tests. A new main board was placed. 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


[185253973] It was reported that the external pulse generator (epg) had a broken connector. The epg was returned for service. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004593495-2020-00341
MDR Report Key9886527
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2019-12-13
Date Mfgr Received2019-12-13
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameTEMPORARY EXTERNAL PACEMAKER
Generic NamePULSE-GENERATOR, PACEMAKER, EXTERNAL
Product CodeDTE
Date Received2020-03-26
Returned To Mfg2019-12-19
Model Number53401
Catalog Number53401
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 2020-03-26

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