MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,450P,PP01,EN,450-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	SAM 450P
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
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 could not be powered 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.
Event or Problem Description
The customer contacted heartsine to report that their device could not be powered 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.
Additional Manufacturer Narrative
Heartsine's investigation was unable to determine the root cause of the reported fault.Information from the device memory shows 8 incomplete power cycles between the 2nd and 3rd october 2025, which would indicate the device was being powered off by removal of the pad-pak.This would support the reported fault.Upon receipt at heartsine, the device underwent extensive testing of all critical functions, performing to specification throughout.No measurable fault was identified that would have prevented the device from powering on or off correctly.However, corrosion and scratches were observed on the on/off button contact pads of the membrane pcb.It is possible that this corrosion had initially compromised the functionality of the on/off button, with the fault clearing while the user repeatedly tested the button, as evidenced by the scratches.Corrosion was also observed on multiple components, including the screws, membrane tail and membrane pcb.The corrosion identified across multiple components alongside the multiple temperatures below the indicated minimum of 0ºc (a low of -13.8°c), would indicate that the device had been stored outside of the indicated conditions.The device was scrapped by heartsine and the customer was provided with a replacement device.

• Brand Name: PACKAGE,450P,PP01,EN,450-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: 20512362
• Report Number: 3004123209-2024-00187
• Device Sequence Number: 21140252
• Product Code: MKJ
• UDI-Device Identifier: 05060167120695
• UDI-Public: 05060167120695
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 02/04/2025

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: 10/09/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• 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