MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,360P,PP01,EN,360-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	SAM 360P
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted heartsine to report that their device did not begin voice prompts and the instructional leds flashed repeatedly upon powering the device on.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.C.
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 customer's device and was unable to duplicate the reported issue.Information from the device memory showed multiple occasions in which the recorded temperature was below the indicated minimum of 0 °c with a low of -19.4°c alongside further low battery fails up to the last log entries on the 29th december 2024.During the investigation, no fault was found on the device that would have caused the low battery fails.The device performed to specification throughout testing at heartsine, the device delivered 1 shock with a test power supply, without fault.The pogo-pins, battery cable and pad-pak crimp connections were verified.No fault was found on the membrane tail or led drive circuitry.The device was temperature cycled from 0-50ºc for 7 days, using a test pad-pak, while performing a self-test every 20 minutes, with no failed self-tests recorded.The cause of the reported issue was determined to be storage outside of the indicated conditions.
Event or Problem Description
The customer contacted heartsine to report that their device did not begin voice prompts and the instructional leds flashed repeatedly upon powering the device on.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: PACKAGE,360P,PP01,EN,360-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: 22367482
• Report Number: 3004123209-2025-00179
• Device Sequence Number: 4436969
• Product Code: MKJ
• UDI-Device Identifier: 05060167120688
• UDI-Public: 05060167120688
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/18/2025

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 360P
• Device Catalogue Number: 360-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2017
• 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