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

Model Number 5392

Device Problem Unexpected Shutdown (4019)

Patient Problems Syncope (1610); Cardiac Arrest (1762); Low Oxygen Saturation (2477)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

Uf/importer report number: (b)(4).Name/address (b)(6).Date user facility became aware of event: (b)(6) 2018.Type of report: initial.Date of this report: (b)(6) 2018.Approximate age of device: 2 years.(b)(4).Report sent to fda: yes, (b)(6) 2018.Location where event occurred: hospital.Report sent to manufacturer: yes, (b)(6) 2018.Manufacturer name and address mfr.Name: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) powered off, without prompt, causing the patient to experience approximately 45 seconds of asystole, a syncopal episode, and an a period of increased oxygen demand.The epg was powered on, and immediately resumed pacing the patient.It was noted that the battery charge indicator showed the battery to have full charge.No further patient complications have been reported as a result of this event.

• 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: 7810689
• MDR Text Key: 118086671
• Report Number: 3004593495-2018-00772
• 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: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2018
• Date Device Manufactured: 11/02/2015
• 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
• Patient Age: 82 YR
• Patient Weight: 78