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

Model Number 5392

Device Problem Computer Operating System Problem (2898)

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

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

Product event summary: analysis could not confirm the reported event.It was noted that the main printed circuit board (pcb) was contaminated, the red and white display wires were pinched with wire exposed, the display flex was contaminated, the battery wire insulation was pinched but the insulation was not compromised, the encoder switch assembly was contaminated, the output connector nuts were discolored, one knob was contaminated, the main seal was pinched and the keyboard flex was contaminated.Functional testing revealed that the device shutdown during testing.Bench testing found that the low battery indicator would not light up when batteries were ejected.Device shut down due to super cap end of life.

Event Description

It was reported that the external pulse generator "locked up." the generator was returned for service.It was requested that this be considered as a warranty repair.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Failure analysis was performed on the main printed circuit board assembly.Visual inspection revealed green contamination on the top side of the main board.Bench analysis found two locations of contamination, around the keypad flex and the lower left corner near the display back light wires.The device case seal was removed to look for ingress, none found.The battery compartment was also checked, no sign of entry.Conclusion: the contamination appeared to originate from inside the device.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.

• 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: 5716020
• MDR Text Key: 47128388
• Report Number: 3004593495-2016-00292
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• 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