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

Model Number 5392

Device Problem Capturing Problem (2891)

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

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) had a capture malfunction.The product has been returned for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: analysis was unable to confirm customer comment of a capture malfunction.Analysis also noted that the hanger assembly was broken, the on/off and enter buttons were out of mechanical specification, the lower case was broken, main seal was pinched, the display was out of electrical specification and the display wires were pinched but wire insulation was not compromised.All defective parts were replaced, and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10011805
• MDR Text Key: 189439189
• Report Number: 3004593495-2020-00492
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169230859
• UDI-Public: 00643169230859
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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
• Patient Outcome(s): Required Intervention