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

Model Number 350P

Device Problem Device Sensing Problem (2917)

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

Event Date 06/10/2023

Event Type  malfunction  

Manufacturer Narrative

Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).The customer provided heartsine with all the available patient information.Patient fields in which information was 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.

Event Description

The distributor contacted heartsine to report that during a patient event their device was unable to detect the patient through the defibrillation electrodes.The customer advised that the device prompted them to ¿connect electrodes¿ when the defibrillation electrodes were connected to the patient.In this state defibrillation therapy may not be available to a patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.

Manufacturer Narrative

The device was not returned to heartsine for evaluation.The cause of the reported issue could not be determined.

Event Description

The distributor contacted heartsine to report that during a patient event their device was unable to detect the patient through the defibrillation electrodes.The customer advised that the device prompted them to ¿connect electrodes¿ when the defibrillation electrodes were connected to the patient.In this state defibrillation therapy may not be available to a patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.

Event Description

The distributor contacted heartsine to report that during a patient event their device was unable to detect the patient through the defibrillation electrodes.The customer advised that the device prompted them to ¿connect electrodes¿ when the defibrillation electrodes were connected to the patient.In this state defibrillation therapy may not be available to a patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.

Manufacturer Narrative

The device was returned to heartsine for evaluation.Heartsine evaluated the customer's device and verified the reported issue.Heartsine observed that inductor, designator l21 was severely cracked which resulted in the reported issue.Heartsine observed that the returned device had scratches and deformation on the device casing together with dents and stress marks on the interior of the upper-case assembly which is near to the damaged l21.These observations are consistent with the device sustaining an impact.Therefore, the cause of the damaged device and component can be traced to the user.The returned device was archived by heartsine.

• Brand Name: PACKAGE, 350P, PP03, IT, 350-STR-IT-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: 17350991
• MDR Text Key: 319303847
• Report Number: 3004123209-2023-00097
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/28/2024

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-IT-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 08/16/2023; 03/27/2024
• Supplement Dates FDA Received: 08/17/2023; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 60 KG