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

Model Number 5392

Device Problems Pacing Intermittently (1443); Device Sensing Problem (2917)

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

Event Date 02/23/2017

Event Type  Injury  

Event Description

It was reported that the external pulse generator (epg) was only pacing the patient intermittently while the patient was being transferred from the operating room (or) to the intensive care unit (icu).When the patient arrived in the icu, the epg was replaced with another unit.The patient was not harmed by the intermittent pacing.Testing at the facility indicated that the epg's output and sensing were within specifications, but it was unknown what the settings were at while being used with the patient.The current status of the epg is unknown.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Analysis summary: analysis was unable to confirm the customer comment of a possible sensing issue.It was noted that the lower case was broken, the keypad was scratched and two case screws were contaminated.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

It was further reported that the product had been returned to service.

• 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: 6469995
• MDR Text Key: 72064090
• Report Number: 3004593495-2017-00220
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

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?: Yes
• 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: 11/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• 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
• Patient Outcome(s): Life Threatening; Required Intervention