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

Model Number 5392

Device Problems Mechanical Problem (1384); Battery Problem (2885); Connection Problem (2900)

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

Event Date 03/18/2020

Event Type  malfunction  

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) needed the battery blade replaced.It was recommended that the epg be returned for service, but its current status is unknown.No patient complications have been reported as a result of this event.It was further reported that the epg was returned.

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the epg required a battery shorting bar.It was noted that the ventricular output connector was dented, keypad window was scratched, lower case boss was broken; both power wires pinched and back wire was exposed, black battery wire intermittently shorted to main printed circuit board (pcb), and two case screws were contaminated.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.

• 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: 9940932
• MDR Text Key: 187088931
• Report Number: 3004593495-2020-00412
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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: 04/06/2020
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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