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

Model Number 5392

Device Problem Pacing Problem (1439)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

The epg failed the ¿atrial pace pulse noise¿ test.The main printed circuit board (pcb) was found to be exhibiting intermittent operation.All found defective parts were replaced and all other identified issues were resolved.The device was re-calibrated and functionally tested and it 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 (epg) was returned from loan, and subsequently tested out of specification.There was no patient involv ement.

Manufacturer Narrative

Failure analysis was performed on the main board.Visual inspection: no anomalies.Benchtop analysis: assembled into a golden unit.Ran on automated test console.Failed atrial pulse noise test, 169.12mv.Measured atrial pulse noise is within the requirements of the atrial pulse noise test (0-100 mv).Measured atrial pulse noise on the bench at 50.0mv.Logs analyzed, no anomalies.Confirmed unit fails atrial pulse noise test, but atrial pulse noise level measured is within device specifications.Conclusion: no defect found.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 8353883
• MDR Text Key: 136631738
• Report Number: 3004593495-2019-00158
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2014
• 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