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 Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
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 audio prompts were distorted.With distorted voice prompts, a lay user may not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Heartsine's investigation of the device duplicated the reported fault.Removal of the speaker from the upper-case assembly revealed a ring of metallic debris around the centre of the speaker cone, which had impeded the vibrations of the speaker and resulted in distorted output.None of the heartsine manufacturing processes create metallic debris, and the speech prompts are verified during samaritan pad 360p final unit test specification.This would indicate that the issue had developed after release from heartsine.The debris in the speaker housing would suggest the device had been stored in the presence of metallic particles, e.G.A factory environment.The device was scrapped by heartsine.
Event or Problem Description
The customer contacted heartsine to report that their device's audio prompts were distorted.With distorted voice prompts, a lay user may not receive the audible instructions on how to properly use the device on a patient which could delay therapy.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: 20953080
• Report Number: 3004123209-2024-00236
• Device Sequence Number: 12873825
• Product Code: MKJ
• UDI-Device Identifier: 05060167120688
• UDI-Public: 05060167120688
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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