MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,360P,PP01,EN,360-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number	350P
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted heartsine to report that their device would not provide any voice prompts.Without voice prompts, the user would not able to use the device properly on a patient 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.
Additional Manufacturer Narrative
The device was not returned to heartsine for evaluation.The cause of the reported issue could not be determined.H3 other text: not returned to manufacturer.
Event or Problem Description
The customer contacted heartsine to report that their device would not provide any voice prompts.Without voice prompts, the user would not able to use the device properly on a patient if needed.There was no patient use associated with the reported event.

• Brand Name: PACKAGE,360P,PP01,EN,360-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 ; 121 friends lane, suite 400; newtown, PA 18940 ; 2158608100
• MDR Report Key: 17569320
• Report Number: 3004123209-2023-00109
• Device Sequence Number: 9006673
• Product Code: MKJ
• UDI-Device Identifier: 05060167120688
• UDI-Public: 05060167120688
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/17/2023

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: 350P
• Device Catalogue Number: 360-STR-US-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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