MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 29901A

Device Problems No Display/Image (1183); Device Difficult to Program or Calibrate (1496); Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the screen of the programmer was not responding to touch or stylus.It was noted that the stylus would not select in the upper right part of the screen and could not expand the electrocardiogram (ecg) dialog box - the arrow jumped away.There was no visible damage found on the display.The display was replaced.Analysis was however unable to confirm or reproduce the customer comment that the programmer would not work when electrocardiogram- ekg cables were plugged into it with no image appearing on the screen.There were no cables returned.All found defective parts were replaced and all other identified issues were resolved.Reconfigured hard drive, reloaded and updated software and the device then passed all final functional and systems tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the screen of the programmer was not responding to touch or stylus.The stylus was not working and the programmer would not work when electrocardiogram (ekg) cables were plugged into it with no image appearing on the screen.The programmer was received into service.There was no patient involvement.

• Brand Name: CARELINK ENCORE PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 10501090
• MDR Text Key: 205916466
• Report Number: 3004593495-2020-01017
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00643169763548
• UDI-Public: 00643169763548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29901A
• Device Catalogue Number: 29901A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2017
• 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