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

Model Number	450P
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Heartsine contacted the customer to request additional information on the patient.The customer provided heartsine with the available patient information.Patient fields in which information is not provided were intentionally left blank.Heartsine has received 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 did not perform analysis.In this state the device may not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.It is unknown if the device contributed to the adverse event.
Event or Problem Description
The customer contacted heartsine to report that their device did not perform analysis.In this state the device may not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.It is unknown if the device contributed to the adverse event.
Additional Manufacturer Narrative
Heartsine evaluated the customer's device but was unable to duplicate the reported issue.Heartsine downloaded the device's memory log and found that the device issued the normal advisory speech prompts to apply the pads to patient.The device continued to log ¿apply pads¿ prompts throughout the event, as an in-range patient impedance was not detected.There was no fault found on the device or the returned pad-pak.The investigation can only suggest that the reported complaint was due to situational factors such as a pad-pak fitment issue or incorrect placement of pads on the patient.The device was scrapped by heartsine.
Additional Manufacturer Narrative
Section b1 adverse event/product problem: adverse event and product problem section b2 outcomes attributed to ae: death section b2 death date: (b)(6) 2022 section h1 type of reportable event: death section h1 event type: d.
Event or Problem Description
The customer contacted heartsine to report that their device did not perform analysis.In this state the device may not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.

• 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 WA 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: 15710233
• Report Number: 3004123209-2022-00143
• Device Sequence Number: 5144408
• Product Code: MKJ
• UDI-Device Identifier: 05060167120695
• UDI-Public: 05060167120695
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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: 450P
• Device Catalogue Number: 450-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 12/16/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/11/2023; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2019
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 93 KG