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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 Degraded (1153)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Product event summary: at analysis it was noted that the white wire on the liquid crystal display (lcd) was pinched and the wire exposed though it was additionally noted that the lcd production scratch protection sheet was never removed from the window.It was also noted that five case screws were contaminated.All found defective parts were replaced and all other identified issues were resolved.The electrical and mechanical parts were inspected, the device was re-calibrated 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
The external pulse generator was returned in accordance with a field action and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
 
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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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7092023
MDR Text Key94143227
Report Number3004593495-2017-00714
Device Sequence Number1
Product Code DTE
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer09/18/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/21/2017
Initial Date FDA Received12/07/2017
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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