MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,450P,PP01,EN,450-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM 450P
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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 would not provide audio 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 with the reported event.
Event or Problem Description
The customer contacted heartsine to report that their device would not provide audio 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 with the reported event.
Additional Manufacturer Narrative
A service representative performed an initial evaluation of the customer¿s device and was able to duplicate the reported issue.On receipt at heartsine, the device was unable to be powered on via the on/off button, therefore there were no voice prompts issued or icon leds illuminated, as per reported fault.This was attributed to corrosion on track 13 (on_button) on the membrane pcb [3].The corrosion on track 13 (on_button) on the membrane pcb had resulted in damage to this track and no connection between the on/off button and the pcba, leading to the device failing to power on via the on/off button.The dirt and scratches on device upper and lower case, corrosion on the membrane pcb, alongside a temperature of -1.4°c recorded on the 16th february 2020, would indicate that the device had been stored outside the indicated conditions.The customer's device shall be scrapped and replaced.

• Brand Name: PACKAGE,450P,PP01,EN,450-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: 22889957
• Report Number: 3004123209-2025-00219
• Device Sequence Number: 8853339
• Product Code: MKJ
• UDI-Device Identifier: 05060167120695
• UDI-Public: 05060167120695
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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 450P
• Device Catalogue Number: 450-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RA2024-3540155
• Patient Sequence Number: 1
• Patient Sex: Unknown