MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03, UK, 350-STR-UK-10; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number 350P

Device Problem No Visual Prompts/Feedback (4021)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as upon receipt the device was found with no instructional leds illuminated.This fault was attributed to the membrane tail was poorly aligned with the j1 connector.Heartsine correctly reinstalled the membrane tail within the connector to resolve the issue.The device was scrapped by heartsine and the customer was provided with a replacement device.

Event Description

The distributor contacted heartsine to report that their customer's device led panel light not responding.This may lead to an inability understanding how to use the device correctly and may lead to a delay or prevent defibrillation therapy.There was no patient involvement reported during the event.

• Brand Name: PACKAGE, 350P, PP03, UK, 350-STR-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS
• 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: 17005742
• MDR Text Key: 315965135
• Report Number: 3004123209-2023-00066
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 05/25/2023

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: 350P
• Device Catalogue Number: 350-STR-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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