MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD TEMPORARY EXTERNAL PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 53401

Device Problems Battery Problem (2885); Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis could not confirm the customer comment of external pulse generator ( epg) shutdown unexpectedly and that there was battery depletion.It was noted that the device passed incoming inspection with no anomalies found.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 epg (external pulse generator) shut off unexpectedly.It was further reported that the battery prematurely depleted.It further reported after performing several tests the user realised that the epg had turned off.It was further reported that the product has been returned for service.There was no patient involvement.

• Brand Name: TEMPORARY EXTERNAL 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 Key: 10345210
• MDR Text Key: 202044304
• Report Number: 3004593495-2020-00801
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• PMA/PMN Number: K162054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53401
• Device Catalogue Number: 53401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Date Manufacturer Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1