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

Model Number 5392

Device Problems Mechanical Problem (1384); Moisture Damage (1405); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was not able to confirm the customer comments regarding water damage, there was no evidence of water damage found inside the device.It was noted that the atrial output encoder turned hard in one section of its turn and the encoder assembly was deemed to be out of specification in a mechanical manner.It was additionally noted that error 200 was generated on the bench which was attributed to the main printed circuit board being out of specification in an electrical manner and that four case screws were contaminated.The electrical and mechanical parts were inspected and all found defective parts were replaced and all other identified issues were resolved.The device was re-calibrated and functionally tested and it passed its final quality assurance tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator's (epg) carrying case had moisture residue.The status of the epg and the case is unknown.There was no patient involvement.It was further reported that the generator was returned to service.It was further reported that the generator subsequently tested out of specification during manufacturer¿s analysis.

• 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: 7418274
• MDR Text Key: 105267228
• Report Number: 3004593495-2018-00274
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169725126
• UDI-Public: 00643169725126
• 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: Other
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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: 01/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• 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