MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATIC EXTERNAL DEFIBRILLATOR

Model Number	SAM 350P
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer contacted heartsine to report their device stopped giving voice prompts while in use.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient.This issue is patient related and the patient survived the event.
Additional Manufacturer Narrative
Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.Heartsine requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer provided heartsine with the available patient information.Patient fields in which information is not provided were intentionally left blank.
Additional Manufacturer Narrative
A clinical revie was performed and there was no device data present to make a determination.It cannot be determined if the device performed to specification.
Event or Problem Description
The customer contacted heartsine to report their device stopped giving voice prompts while in use.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient.This issue is patient related and the patient survived the event.
Additional Manufacturer Narrative
Heartsine evaluated the device and could not duplicate the issue.No issue was found with the device.It was noted that the pad-pak used during the event was expired, but the investigation was unable to determine if this led to device suddenly powering off as no pad-pak was returned for the investigation.Cause of the reported issue was traced to the user, due to an incorrectly seated pad-pak which led to the user incidentally powering the device off when removing or applying the electrode pads during the event.The device was archived by heartsine and the customer received a replacement.
Event or Problem Description
The customer contacted heartsine to report their device stopped giving voice prompts while in use.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient.This issue is patient related and the patient survived the event.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-10
• Common Device Name: AUTOMATIC 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: 21861676
• Report Number: 3004123209-2025-00131
• Device Sequence Number: 7841672
• Product Code: NSA
• UDI-Device Identifier: 05060167120671
• UDI-Public: 05060167120671
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 09/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 08/06/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/06/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2019
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White