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

Model Number	SAM 450P
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Heartsine contacted the customer to request additional information on the patient.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.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 did not analyze when connected to a patient.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The patient did not survive.
Additional Manufacturer Narrative
Heartsine evaluated the customer's device and verified the reported issue.It was observed through the electronic records of the device, the patient presented with a non-shockable rhythm, asystole.Following this, the device suddenly powered off.Heartsine determined that this was attributed to a failed +ve pogo-pin.Heartsine performed a clinical review of the reported issue observed through the electronic records of the event that chest compressions were performed when the pads were placed, artificing the ecg.As a result the device determined the rhythm to be shockable.When chest compressions stopped, the patient presented in asystole, a non-shockable rhythm.It could not be determined if the device performed as intended.The customer received a replacement device and the returned device archived by heartsine.
Event or Problem Description
The customer contacted heartsine to report that their device did not analyze when connected to a patient.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The patient did not survive.

• Brand Name: PACKAGE,450P,PP01,EN,450-STR-US-10
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS
• 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: 22294185
• Report Number: 3004123209-2025-00169
• Device Sequence Number: 18210556
• 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
• Report Date (Section B): 11/06/2025

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 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: 05/28/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2019
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White