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

Model Number 5392

Device Problem Computer Software Problem (1112)

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

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis : analysis could not confirm customer comment (epg) displayed an error message "button press detected".Error message has normal operation when on/off button is pushed down for too long.Hanger assembly is broken.Backlight issue, connector on main printed circuit board (pcb).Main pcb is also contaminated.Upper and lower cases are broken.Keypad flex is contaminated.Encoder assembly and four knobs are contaminated.Display flex and display frame are contaminated.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 (epg) displayed an error code that displayed "button press detected".There was no patient involvement.It was further reported that the epg was returned for service.It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.

• 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: 9182565
• MDR Text Key: 174962830
• Report Number: 3004593495-2019-01065
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: 09/17/2019
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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