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

Model Number	360P
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
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 did not emit audio prompts.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
Additional Manufacturer Narrative
Heartsine has made multiple attempts to contact the customer regarding the status of their device, but no response has been received from the customer.The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time.The cause of the reported issue could not be determined.If the device is returned to the manufacturer the investigation will be reopened.
Event or Problem Description
The customer contacted heartsine to report that their device did not emit audio prompts.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
Additional Manufacturer Narrative
Hearsine's investigation confirmed the reported fault as upon receipt, the device would not issue audio prompts.A visual inspection of the speaker cables identified that the red speaker cable was severed in the region where the rim of the upper case meets the lower case.This indicates that the cable had been damaged during pairing of the two cases at manufacture.The fault could not be replicated after replacing the speaker.The device was scrapped by heartsine and the customer was provided with a replacement device.
Event or Problem Description
The customer contacted heartsine to report that their device did not emit audio prompts.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.

• Brand Name: PACKAGE,360P,PP01,EN,360-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: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 19458951
• Report Number: 3004123209-2024-00078
• Device Sequence Number: 6652972
• Product Code: MKJ
• UDI-Device Identifier: 05060167120688
• UDI-Public: 05060167120688
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/11/2024

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: 360P
• Device Catalogue Number: 360-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 10/30/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/14/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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