MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PAD-PAK 01; COMBINED, SINGLE USE, BATTERY AND ELECTRODE UNIT

Model Number	PAD-PAK-01
Medical Device Problem Codes	Failure to Power Up (1476); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
Event or Problem Description
The customer contacted heartsine to report that their device's battery was depleted.As a result, the device may not be able to power on to deliver defibrillation therapy, if needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
The product was not returned to heartsine for evaluation.The cause of the reported issue was not determined.
Event or Problem Description
The customer contacted heartsine to report that their device's battery was depleted.As a result, the device may not be able to power on to deliver defibrillation therapy, if needed.There was no report of patient use associated with the reported event.

• Brand Name: PAD-PAK 01
• Common Device Name: COMBINED, SINGLE USE, BATTERY AND ELECTRODE UNIT
• 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: 24735693
• Report Number: 3004123209-2026-00354
• Device Sequence Number: 9270008
• Product Code: MKJ
• UDI-Device Identifier: 05060167120466
• UDI-Public: 05060167120466
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: H1407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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