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

Model Number 350P

Device Problem Device Sensing Problem (2917)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

A distributor contacted heartsine to report that a customer's device was unable to detect the patient through the defibrillation electrodes.The customer advised that the device prompted, "stick the electrodes on the patient's chest", although the electrodes had been attached to the patient.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, the customer advised that the patient survived to hospital admission.

Manufacturer Narrative

Heartsine contacted the customer to request additional information on the patient.The customer provided stryker with all the available patient information.Patient fields in which information is not provided were intentionally left blank.Heartsine will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.

Manufacturer Narrative

Heartsine evaluated the customer's device and was unable to verify or duplicate the reported issue.Based on the investigation findings and a clinical/useability review , it can be suggested that the reported issue was due to user error, a potential pad placement issue.The customer received a replacement device and the returned device scrapped by heartsine.

Event Description

A distributor contacted heartsine to report that a customer's device was unable to detect the patient through the defibrillation electrodes.The customer advised that the device prompted, "stick the electrodes on the patient's chest", although the electrodes had been attached to the patient.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however, the customer advised that the patient survived to hospital admission.

• Brand Name: PACKAGE, 350P, PP03, PO, 350-STR-PO-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: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 18129939
• MDR Text Key: 328028383
• Report Number: 3004123209-2023-00159
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 01/04/2024

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-PO-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• 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 Weight: 100 KG