MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, 1X PAD-PAK-03, FRENCH, 350-STR-FR-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 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow up report.

Event Description

The customer contacted heartsine to report that their device did not shock as expected.There was no patient involvement in this event.

Event Description

The customer contacted heartsine to report that their device did not shock as expected.There was no patient involvement in this event.

Manufacturer Narrative

The device was returned to heartsine for evaluation and the reported issue was verified and duplicated.Investigation found a failure of capacitor c22 was the cause of the reported issue.This device was scrapped and the customer received a replacement device.

Manufacturer Narrative

The device was not returned for evaluation.The cause of the reported issue could not be determined.H3 other text : device not returned to manufacturer.

Event Description

The customer contacted heartsine to report that their device did not shock as expected.There was no patient involvement in this event.

• Brand Name: PACKAGE, 350P, 1X PAD-PAK-03, FRENCH, 350-STR-FR-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: 17758782
• MDR Text Key: 323913334
• Report Number: 3004123209-2023-00124
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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-FR-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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