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

Model Number	450P
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted heartsine to report that their device could not power 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 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 power 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 confirmed the reported fault and determined the root cause to be a misaligned membrane tail.The fault could not be replicated after correctly reinstalling the membrane tail, this would confirm the reported failure had been due to the misalignment of the membrane tail.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: 20241921
• Report Number: 3004123209-2024-00167
• Device Sequence Number: 8090332
• Product Code: MKJ
• UDI-Device Identifier: 05060167120695
• UDI-Public: 05060167120695
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/23/2025

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: 450P
• Device Catalogue Number: 450-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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