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

Model Number 5392

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product analysis: at analysis it was noted that though the unit was received mechanically intact, it failed its incoming testing on the automated test system on the atrial pace pulse noise test and it was attributed to the main board being defective.The unit was cleaned and inspected, the main board was replaced and the unit was tested and calibrated on the automated test system and passed.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator which was returned for preventive maintenance subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.

Manufacturer Narrative

Failure analysis was performed on the main board.Visual inspection revealed no anomalies.The main board was assembled into a golden unit and ran on the automated test console.The unit failed the atrial pulse noise test.The atrial pulse noise was measured on the bench and was found to be within the requirements of the atrial pulse noise test.The logs were analyzed and no errors were found.It was confirmed that the unit failed the atrial pulse noise test, but the atrial pulse noise level measured was within device specifications.Conclusion: no defect found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7418254
• MDR Text Key: 105372670
• Report Number: 3004593495-2018-00273
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 06/29/2018; 08/08/2018
• Supplement Dates FDA Received: 07/09/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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