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

Model Number 5392

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment of the rate control not working.Analysis noted that the encoder assembly was out of electrical specification, atrial output connector was broken, hanger was bent and cracked, keypad window was scratched, one control knob was contaminated, lower case was broken, main label was damaged, main seal was damaged and missing section by battery drawer, all six plugs were damaged, need battery shortening bar, both display wires were pinched (not compromised), both wires in lower case were pinched (not compromised) and wires were incorrectly routed over the battery compartment.Analysis noted that the epg had evidence of a non-manufacturer service person disassembling and reassembling the epg.The main seal was damaged, missing section by battery drawer, six plugs were damaged with tool marks, both display wires were pinched and both battery wires in lower case were pinched.All found 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.

Event Description

It was reported that the external pulse generator ( epg) knob was not working.It was noted that during a rate change the dial would turn but the pacing rate did not change in the 78-80 range.The device was returned for service.There was no patient involvement.

• 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: 10313478
• MDR Text Key: 200034671
• Report Number: 3004593495-2020-00771
• 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
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: 07/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• 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