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

Model Number 5392

Device Problems Degraded (1153); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: manufacturer's analysis confirmed the customer comment that the device had an error that would not clear.It was also noted that both wires on the liquid crystal display (lcd) were pinched without compromise, however the red wire was exposed.The wires were also routed incorrectly over the battery compartment.All found defective parts were replaced and all other identified issues were resolved.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) presented with an error that would not clear.The epg has been returned for repair.There was no patient involvement.It was further reported that the returned epg subsequently tested out of specification during manufacturer¿s analysis.

Manufacturer Narrative

Failure analysis was performed on the main board.Visual inspection revealed no anomalies.The main board was then assembled into a golden unit.The device powered on to an error.The eeprom (electrically erasable programmable read-only memory) was then replaced.The device was run on the automated test console and all tests passed.The logs were reviewed.Three different errors were displayed in the logs.Conclusion: the customer complaint of an error on power-up was confirmed.The failure was caused by a corrupt eeprom.One error was confirmed in the log, but could not be reproduced on the bench.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: 6626952
• MDR Text Key: 77295237
• Report Number: 3004593495-2017-00329
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169508767
• UDI-Public: 00643169508767
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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: 03/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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