MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number HDF-3500

Device Problem Inappropriate Audible Prompt/Feedback (2280)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Event Description

The distributor contacted heartsine to report that their device was programmed with the incorrect language.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault of incorrect language.The reported fault was attributed to a manufacturing failure.The device was scrapped by heartsine and the customer was provided with a replacement device.

• Brand Name: UNKNOWN_MEDICAL - BELFAST_PRODUCT
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 18564859
• MDR Text Key: 333498884
• Report Number: 3004123209-2024-00008
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HDF-3500
• Device Catalogue Number: UNK_BEL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1