MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10,BEL; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problem Failure to Deliver Energy (1211)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

A clinical evaluation was performed and it was found that the patient presented a non-shockable rhythm throughout the event.The instances where a shock was advised was due to chest compressions performed during the analysis period of the device algorithm.The sam 350p did not cause or contribute to the patient¿s outcome.Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.Heartsine contacted the customer to request additional information on the patient.The customer provided heartsine with the available patient information.

Event Description

A distributor contacted heartsine to report that a customer¿s device did not provide defibrillation energy during a cardiac arrest.This issue has the potential to either delay, or prevent, defibrillation from being delivered.The patient associated with the reported event did not survive.A clinical review was performed and concluded that the device did not cause or contribute to the patient outcome.

Manufacturer Narrative

Heartsine evaluated the customer's device but was unable to duplicate the reported issue.No fault was found on the device or the returned pad-pak during the investigation.The device was scrapped by heartsine.

Event Description

A distributor contacted heartsine to report that a customer¿s device did not provide defibrillation energy during a cardiac arrest.This issue has the potential to either delay, or prevent, defibrillation from being delivered.The patient associated with the reported event did not survive.A clinical review was performed and concluded that the device did not cause or contribute to the patient outcome.

• Brand Name: PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10,BEL
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• 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: 15776489
• MDR Text Key: 307885268
• Report Number: 3004123209-2022-00147
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 01/09/2023

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-BAS-TH-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2019
• 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 Age: 101 YR
• Patient Sex: Female
• Patient Weight: 45 KG