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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2018
Event Type  Malfunction  
Manufacturer Narrative

Analysis summary: analysis was unable to confirm the customer comment of "box not working". It was noted that the battery wires were pinched but the wire insulation was not compromised, the hanger assembly and output connector assembly were both broken, the display wire was pinched and the insulation not compromised and the encoder assembly and two knobs were contaminated. The electrical and mechanical parts were inspected and all found defective parts were replaced and all other identified issues were resolved. The device was recalibrated and functionally tested and passed its final quality assurance tests. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the "box [external pulse generator] was not working. " it was verified through follow-up that this was the only information available. The generator was returned for service. No patient complications have been reported as a result of this event.

 
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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 Key7414401
MDR Text Key105180028
Report Number3004593495-2018-00184
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 BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 04/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2018
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 Manufacturer01/30/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/26/2016
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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