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

Model Number 5392

Device Problems Computer Software Problem (1112); Failure of Device to Self-Test (2937)

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

Event Date 12/04/2013

Event Type  malfunction  

Manufacturer Narrative

Product event summary: initial analysis confirmed the reported event of "810" errors, main printed circuit board (pcb) was out of electrical specification.It was also noted that the keypad looked to be lifted a little above the doo button and contaminated below the button on the inside, the ring attachment looked contaminated, the display glass surface was contaminated, the encoder flex, all encoders were twisted, however, they were working when tested and within part specifications.Functional testing failed due to main pcb.The device powered up after device log reset from incoming functional testing.Failure analysis was performed on the device.The log showed multiple occurrences of the 810 error, this error indicates the occurrence of a device self-test failure.There were also occurrences of a 721 error, this error indicates a capacitor voltage above high threshold.Visual inspection revealed residue on the inside surface of the viewing window of the keypad, the residue appeared to be the result of liquid ingress around the doo button through separated layers of the switch membrane keypad.No visual anomalies observed on pcb.Bench analysis revealed no errors after the initial 810 error was cleared.Could not reproduce failure modes resulting in logging of either the 810 or 721 error codes.The keypad was sent to the chemical technologies lab for analysis.Residue was determined to be primarily consistent with that of a surfactant/detergent - sodium dodecylbenzenesulfonate.No anomalies were found with solder joint integrity.Conclusion: the 0810 and 721 error code producing failures could not be reproduced.Inspection revealed residue on the inside surface of the keypad viewing window indicative of fluid ingression.It was determined this was caused by keypad layer separation in vicinity of the doo button.

Event Description

It was reported there was an error code that displayed which indicates that the power on self test failed.The device was returned for repair.No patient complications were reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

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): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3615877
• MDR Text Key: 12116757
• Report Number: 3004593495-2014-00006
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2013

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: 01/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 02/08/2014
• Supplement Dates Manufacturer Received: Not provided; 04/09/2014
• Supplement Dates FDA Received: 06/09/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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