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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 Clip (758); Knob (861); Break (1069); Calibration Problem (2890); Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 06/26/2018
Event Type  Malfunction  
Manufacturer Narrative

Product analysis: analysis confirmed the reported broken knob and hanger. Analysis also noted that one control knob was missing, two control knobs were corroded, the keypad window was scratched, the encoder assembly was contaminated, and two case screws were contaminated. All found defective parts were replaced and all other identified issues were resolved. The device passed final functional and system tests. No other anomalies were found. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the external pulse generator (epg) had a broken off pulse knob and the hanger clip was broken. The epg was returned for service. There was no patient involvement.

 
Manufacturer Narrative

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

 
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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 Key7715612
MDR Text Key114946424
Report Number3004593495-2018-00686
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 HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/05/2018
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 Manufacturer07/03/2018
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? Yes
Date Device Manufactured11/20/2015
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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