MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; 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	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted heartsine to report that their device did not provide voice prompts.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no report of patient use associated to the reported 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.
Additional Manufacturer Narrative
Heartsine evaluated the device and verified the issue.The cause was determined to be a faulty crystal y4, which is a critical component on the pcba speech circuitry.The device recorded multiple temperatures outside of the indicated temperature range of 0-50°c which may have contributed to the failure of y4.The device was scrapped by heartsine.
Event or Problem Description
The customer contacted heartsine to report that their device did not provide voice prompts.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no report of patient use associated to the reported event.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-10
• Common Device Name: 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: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 21688603
• Report Number: 3004123209-2025-00102
• Device Sequence Number: 13070026
• Product Code: NSA
• UDI-Device Identifier: 05060167120671
• UDI-Public: 05060167120671
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/01/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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