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

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	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted heartsine to report that their device would not power on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported 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 would not power on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Heartsine evaluated the customer's device and was unable to duplicate or verify the reported issue.The device powered on normally during the evaluation using a test battery.Information from the device memory suggest that the pad-pak was not correctly installed or depleted.However, the pad-pak was not returned for evaluation, therefore the investigation was unable to confirm the reported issue.The cause of the reported issue could not be conclusively determined.

• 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: dara friedman ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 17180340
• Report Number: 3004123209-2023-00079
• Device Sequence Number: 20430855
• Product Code: MKJ
• UDI-Device Identifier: 05060167120695
• UDI-Public: 05060167120695
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/24/2023

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
• Date Returned to Manufacturer: 06/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• 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