MAUDE Adverse Event Report: HeartSine Technologies LTD HEARTSINE SAMARITAN PAD 350P; Over-the-counter automated external defibrillator

Model Number	SAM 350P
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Heartsine continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted heartsine to report that their device is not giving any audible prompts.Without audible prompts, a user may be unable to use the device to deliver defibrillation therapy to a patient, if needed.There was no report of patient use associated with the reported event.

• Brand Name: HEARTSINE SAMARITAN PAD 350P
• Common Device Name: Over-the-counter automated external defibrillator
• 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: juan salazar ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; +1(425)867-4577
• MDR Report Key: 25280047
• Report Number: 3004123209-2026-00384
• Device Sequence Number: 10094967
• Product Code: NSA
• UDI-Device Identifier: 05060167120671
• UDI-Public: 05060167120671
• 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): 09/03/2026

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: SAM 350P
• Device Catalogue Number: 350-STR-US-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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