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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL
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PLEXUS MANUFACTURING SDN. BHD DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5392
Device Problem Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 08/17/2020
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 atrial and ventricular connectors of the external pulse generator (epg) would not hold cable in place.The epg was received into service.There was no patient involvement.
 
Manufacturer Narrative
Product analysis: analysis of the external pulse generator (epg) was able to confirm the customer comments of broken output connectors.Analysis also noted that the hanger was broken, backlight issue due to loose connector on main printed circuit board (pcb), lower case boss was broken, and 4 case screws were contaminated.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
DUAL CHAMBER TEMPORARY 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
MDR Report Key10470511
MDR Text Key204894674
Report Number3004593495-2020-00987
Device Sequence Number1
Product Code DTE
UDI-Device Identifier00643169725126
UDI-Public00643169725126
Combination Product (y/n)N
PMA/PMN Number
K150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
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 Manufacturer08/21/2020
Date Manufacturer Received09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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