MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number 350P

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 11/19/2022

Event Type  malfunction  

Manufacturer Narrative

Heartsine contacted the customer to request additional information on the patient.The customer provided heartsine with the available patient information.Patient fields in which information is not provided were intentionally left blank.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 customer's device did not deliver appropriate defibrillation therapy.This issue is patient related; however there was no adverse event reported.

Event Description

The customer contacted heartsine to report that their customer's device did not deliver appropriate defibrillation therapy.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Heartsine evaluated the customer's device but could not verify or duplicate the reported issue.Heartsine performed a clinical review and concluded the device use did not contribute to the outcome of the patient's event.The device performed to specification.Heartsine retained the device.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-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: dara friedman ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 16994439
• MDR Text Key: 315866142
• Report Number: 3004123209-2023-00065
• Device Sequence Number: 1
• Product Code: NSA
• UDI-Device Identifier: 05060167120671
• UDI-Public: 05060167120671
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2014
• 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
• Patient Age: 80 YR
• Patient Sex: Male