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

Model Number 5392

Device Problems Break (1069); Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: manufacturer¿s analysis confirmed the customer comment that the device had a broken hanger assembly, however could not confirm the comment that the connector was loose.The internal rattling comment was also confirmed; the main printed circuit board (pcb) assembly had a loose screw, and the display frame had stripped out a screw boss.The output connector assembly was broken, and the display wire was pinched without compromise to the insulation.All found defective parts were replaced and all other identified issues were resolved.A good faith effort will be made to obtain the applicable information relevant to the report.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 loose connector, and the hanger assembly was broken.It was also reported that the epg had "internal rattling." the epg has been returned for repair.There was no patient involvement.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6468676
• MDR Text Key: 72180767
• Report Number: 3004593495-2017-00198
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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