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

Model Number 53401

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported when using the external pulse generator (epg) it will initially pace normally but appears to experience a reset and it goes back to default settings and not what the device was previously set to and pacing at.The external pulse generator (epg) was reported to be working on an old firmware version.It was advised that the unit should be removed from service and sent in for servicing in order to get the correct firmware update installed.A patient was connected with the device at the time the event occurred.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The external pulse generator (epg) passed all incoming inspection.Power on reset (por) firmware was updated.The epg passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator (epg) was returned for service.

• 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: 9503415
• MDR Text Key: 172218453
• Report Number: 3004593495-2019-01339
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169723160
• UDI-Public: 00643169723160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• 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: 03/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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
• Patient Outcome(s): Required Intervention