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

Model Number 5392

Device Problems Device Difficult to Program or Calibrate (1496); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product event summary: at analysis it was determined that the encoder assembly was out of specification in an electrical manner.It was additionally noted that the lower case battery drawer was contaminated with rust, the outside of the keypad window was scratched and dotted with spots and multiple errors indicated that the main printed circuit board was out of specification in an electrical manner.It was also noted that this unit was in need of the updated battery shorting bar design.All found defective parts were replaced and all other identified issues were resolved.The electrical and mechanical parts were inspected, the device was re-calibrated and functionally tested and passed its final quality assurance tests.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator was returned with no information and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

Manufacturer Narrative

Failure analysis was performed on the main board.Visual inspection revealed no anomalies.The board was assembled into a golden unit.No error displayed.All tests passed on the automated test console.The log was reviewed, 4 different error numbers were verified in the log.Conclusion: the reported event was confirmed.Errors were verified in the logs but could not be reproduced on the bench.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: 7091335
• MDR Text Key: 94487414
• Report Number: 3004593495-2017-00690
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• 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: 08/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2014
• 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