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	06/08/2023
Type of Reportable Event	Malfunction
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 requested the 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 kept prompting "connect pads" when the defibrillation electrodes had already been applied to the patient.In this state the device may not be able to deliver defibrillation therapy, if needed.This issue is patient related; however, no adverse event was reported.
Additional Manufacturer Narrative
Heartsine evaluated the customer's device and was not able to duplicate the reported issue.The device performed as expected during testing.The cause of the reported issue could not be determined.The customer received a replacement and this device will be archived by heartsine.
Event or Problem Description
The customer contacted heartsine to report that their device kept prompting "connect pads" when the defibrillation electrodes had already been applied to the patient.In this state the device may not be able to deliver defibrillation therapy, if needed.This issue is patient related; however, no adverse event was reported.

• 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: dara friedman ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 17235410
• Report Number: 3004123209-2023-00086
• Device Sequence Number: 14879323
• Product Code: MKJ
• UDI-Device Identifier: 05060167120695
• UDI-Public: 05060167120695
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2019
• 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
• Patient Sex: Unknown