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

Model Number 5392

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) had a possible broken ventricular output selector.The epg is expected to be returned for service.There was no patient involvement.

Manufacturer Narrative

Product analysis:analysis determined that the upper case was damaged/cracked.The menu knob was broken/cracked, there was a missing button, there were corroded knobs at the metal lower side, the device was sticky, and the lower case was also polluted and very sticky.During inspection, it was noted that the printed circuit board (pcb) showed some liquid reside and corrosion reside on the main board.The reside was noted to be found on several places and parts.This explained the corrosion found on the knobs.Analysis determined that the device was not reliable due to the corrosion on the main board, so the device was not repaired.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the epg was returned.

Manufacturer Narrative

If 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: 9397505
• MDR Text Key: 175458974
• Report Number: 3004593495-2019-01253
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

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: 11/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 01/31/2020; 02/26/2020
• Supplement Dates FDA Received: 02/26/2020; 02/27/2020
• 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