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

Model Number 53401

Device Problems Electrical /Electronic Property Problem (1198); Nonstandard Device (1420)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product analysis: at analysis it was determined that the main printed circuit board was out of specification in an electrical manner.The device also received its requested firmware update.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

The external pulse generator which was returned in accordance with instructions affiliated with the field corrective action 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: no anomalies.Benchtop analysis: assembled into a golden unit.Powered on the external pulse generator (epg), rapid rate light emitting diode (led) is constantly illuminated.Ran on the automated test console.Passed all tests.Compared voltages of transistor with a known good unit.Pins 2, 3, and 5, measured at different voltages.Pin 2 0.043v, pin 3 2.7v, and pin 5 0.0049v.Good unit measured at pin 2 0.003v, pin 3 3.3v, pin 5 0.003v.Replaced transistor with a known good part.Powered on the epg, rapid rate led was no longer illuminated.No log data was provided.Conclusion: confirmed customer complaint of constantly illuminated rapid rate led.Failure caused by faulty transistor.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: 7716601
• MDR Text Key: 115106978
• Report Number: 3004593495-2018-00688
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2018

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: 53401
• Device Catalogue Number: 53401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/26/2018
• Supplement Dates FDA Received: 10/03/2018; 11/06/2018
• 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
• Removal/Correction Number: Z-2317-2018
• Patient Sequence Number: 1