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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 Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Date 07/21/2020
Event Type  malfunction  
Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that the epg would not power on.The main printed circuit board (pcb) was contaminated.It was also noted that the output connector assembly and upper case was broken, the keypad flex, encoder assembly, four knobs and the display were contaminated, the lower case was contaminated and broken and six plugs were damaged.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.
 
Event Description
It was reported that the external pulse generator (epg) would not power on.The epg was returned for service.There was no patient involvement.The epg subsequently tested out of specification during manufacturer's analysis.
 
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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
Manufacturer (Section G)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY   11900
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10438615
MDR Text Key203904855
Report Number3004593495-2020-00939
Device Sequence Number1
Product Code DTE
UDI-Device Identifier00643169508767
UDI-Public00643169508767
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
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 Manufacturer07/27/2020
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2015
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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