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

Model Number 5392

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis was able to confirm the epg failed the power up test.The main printed circuit board (pcb) was out of electrical specification.Analysis also noted that the output connector assembly was broken, the lower case was damaged, and the display wire was pinched without compromised insulation.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) failed the power up test.The epg was returned for service and 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: capacitor missing.Benchtop analysis: powered on device with known good batteries.Device froze on startup.All display segments were lit, and the ventricular pace led was lit.The ventricular pace led indicates a self-test error, error detected initializing eeprom (electrically erasable programmable read-only memory).Successfully executed a firmware update using the automated test console.Powered on device to desktop.Ran final functional test on the automated test console.All tests passed.Capacitor partially broken off the printed circuit board (pcb).Conclusion: confirmed customer complaint, device freezes on boot.Failure caused by microprocessor firmware self-test failure.F 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: 8838947
• MDR Text Key: 152618158
• Report Number: 3004593495-2019-00761
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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: 07/05/2019
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2015
• 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