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

Model Number 5392

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis was unable to confirm the customer's comment regarding the error message "button press detected" being displayed on the external pulse generator.Hanger assembly was broken.Backlight issue, connector on main printed circuit board (pcb).Main pcb was contaminated.Upper case was contaminated.Keypad flex was contaminated.Encoder assembly was contaminated.Four knobs were contaminated.Lower case was broken and contaminated.Main seal was contaminated.Display was contaminated.Display frame was contaminated.Insulator label was contaminated.Five case screws were contaminated, one was missing.Two main pcb screws were contaminated.Device failed incoming functional testing.Six self-test stuck buttons detected, only two self-test stuck buttons recovered.All found defective parts were replaced and all other identified issues were resolved.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 displayed an error message "button press detected".It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.The device was returned for repair.There was no patient involvement.

• 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: 10453186
• MDR Text Key: 204341595
• Report Number: 3004593495-2020-00967
• 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
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 07/17/2020
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• 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