MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,1X PAD-PAK-03, DUTCH, 350-STR-NL-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 350P

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

Heartsine technologies ltd continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted heartsine to report their device did not deliver a shock as expected.There was no patient involvement reported with the event.

Event Description

The customer contacted heartsine to report their device did not deliver a shock as expected.There was no patient involvement reported with the event.

Manufacturer Narrative

Heartsine evaluated the customer¿s device and was able to duplicate and verify the reported issue.The root cause of the reported issue was determined to be due a fractured solder joint on capacitor c22 resulting in the high voltage capacitors failing to discharge and deliver shock.This device was scrapped by heartsine and the customer received a replacement device.

• Brand Name: PACKAGE, 350P,1X PAD-PAK-03, DUTCH, 350-STR-NL-10
• 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: dara friedman ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 17243592
• MDR Text Key: 318552048
• Report Number: 3004123209-2023-00088
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123881
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 350P
• Device Catalogue Number: 350-STR-NL-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• 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
• Patient Sex: Male