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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD TEMPORARY EXTERNAL PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL
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PLEXUS MANUFACTURING SDN. BHD TEMPORARY EXTERNAL PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 53401
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 05/03/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's analysis indicated that the external pulse generator (epg) failed incoming testing.The main printed circuit board (pcb) was out of specification.The epg was repaired and returned to use.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The external pulse generator (epg) was returned for testing and calibration and subsequently tested out of specification during manu facturer's analysis.There was no patient involvement.
 
Manufacturer Narrative
Failure analysis was performed on the main board.Visual inspection: no anomalies.Benchtop analysis: super caps are not placed on the main board.The super cap board from device was not provided.Testing on the automated test console after replacing the main board passed all tests.Assembled the main board into a golden unit.Powered on to the desktop with no issues.Ejected the batteries and allowed the device to remain powered by the super caps.Device remained powered for 3 minutes and 25 seconds.Ran device on the automated test console.Passed all tests.Conclusion: could not confirm customer complaint.No defect found.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
TEMPORARY EXTERNAL PACEMAKER
Type of Device
PULSE-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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8623583
MDR Text Key145497484
Report Number3004593495-2019-00470
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number53401
Device Catalogue Number53401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Date Manufacturer Received08/22/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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