MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HDF-3500; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number HDF3500

Device Problem Failure to Power Up (1476)

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

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

Heartsine continues to investigate the reported issue and will submit a supplemental report on this event to the fda.

Event Description

The distributor contacted heartsine to report that the customers device would not provide any audio.Upon further investigation by the distrib, it was observed that the device would not turn on, which would result in no audio.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.

Manufacturer Narrative

Heartsine evaluated the customer's device and verified the reported issue.It was observed that 5 of the 6 battery cells were depleted.Visual inspection of the pad-pak revealed a sharp weld spur on one of the battery cells, which had penetrated the insulation on an adjacent cell.This caused a current path to this cell, which resulted in 5 of the 6 cells discharging to 0.The device was replaced for the customer and the returned device scrapped.

Event Description

The distributor contacted heartsine to report that the customers device would not provide any audio.Upon further investigation by the distrib, it was observed that the device would not turn on, which would result in no audio.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.

• Brand Name: HDF-3500
• 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: todd bandy ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 15987948
• MDR Text Key: 308092587
• Report Number: 3004123209-2022-00164
• Device Sequence Number: 1
• Product Code: NSA
• 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,Followup
• Report Date: 02/21/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: HDF3500
• Device Catalogue Number: UNK_BEL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• 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