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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD PULSE-GENERATOR, PACEMAKER, EXTERNAL

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PLEXUS MANUFACTURING SDN. BHD PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5392
Device Problems Knob (861); Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2018
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the external pulse generator had its outer plastic knob broken off and that its metal trim knob had been pushed inside the device. The generator was returned for service. No patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Product analysis: analysis confirmed the customer comment that the knob was missing and the upper case was broken and additionally noted that the lower case was broken, the output connector assembly was broken, the display wires were pinched with the wire insulation exposed, the display frame bosses were stripped, the encoder switch assembly was contaminated and the main seal was broken. All found defective parts were replaced and all other identified issues were resolved. The device then passed all final functional tests. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

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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 Key7714715
MDR Text Key115064529
Report Number3004593495-2018-00683
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,HEALTH
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/24/2018
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 Manufacturer07/23/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/29/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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