MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	350P
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted heartsine to report their device would not power on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Heartsine has requested the 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 their device would not power on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
A service representative performed evaluation of the customer¿s device and was able to verify the reported issue.Upon receipt the device failed to power on upon pressing the on/off button.The fault was attributed to corrosion on the on/off button and its contact pads on the membrane pcb.This had resulted in the on/off button dome failing to make contact with its contact pads on the membrane panel; therefore, the device was unable to be powered on.Furthermore, corrosion on the underside of the shock button dome had prevented the shock button from functioning.The corrosion indicates that the device was stored outside of the indicated conditions.The device shall be scrapped and replaced.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-10
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 23976921
• Report Number: 3004123209-2026-00021
• Device Sequence Number: 18796904
• Product Code: MKJ
• UDI-Device Identifier: 05060167120671
• UDI-Public: 05060167120671
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 04/20/2026

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: 350P
• Device Catalogue Number: 350-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown