MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PAD-PAK-01; AUTOMATED EXTERNAL DEFIBRILLATOR ELECTRODE

Model Number	PAD-PAK-01
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Heartsine evaluated the pad-pak and duplicated the reported issue.The cause of the issue was determined to be a blown fuse.The device was not returned to heartsine, therefore further root cause could be determined.The pad-pak was scrapped and the customer received a replacement pad-pak.
Event or Problem Description
The customer contacted heartsine to report that their device's pad-pak was dead, and does not power on the device.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.

• Brand Name: PAD-PAK-01
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR ELECTRODE
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer Contact: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 24671448
• Report Number: 3004123209-2026-00351
• Device Sequence Number: 18732037
• Product Code: MKJ
• UDI-Device Identifier: 05060167120466
• UDI-Public: 05060167120466
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PAD-PAK-01
• Device Catalogue Number: PAD-PAK-01
• Device Lot Number: H1178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown