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

Model Number 350P

Device Problem Defibrillation/Stimulation Problem (1573)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

The customer provided heartsine with all the available patient information.Patient fields in which information was 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 a discrepancy during the post event review of the electronic data from their device.The customer reported the following: "after our physician reviewed the event and the ecg, it is their recommendation that the aed did not appear to deliver the appropriate shock and may be defective." this issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

The device was returned to heartsine for evaluation.The reported issue could not be duplicated.Review of the software logs indicate the device performed as expected and advised and delivered a shock only one time when a shockable rhythm was detected.The device will be archived by heartsine.The customer received a replacement device.

Event Description

The customer contacted heartsine to report a discrepancy during the post event review of the electronic data from their device.The customer reported the following: "after our physician reviewed the event and the ecg, it is their recommendation that the aed did not appear to deliver the appropriate shock and may be defective." this issue is patient related; however there was no adverse event reported.

• Brand Name: PACKAGE,350P,PP01,EN,350-STR-US-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 17066275
• MDR Text Key: 317222448
• Report Number: 3004123209-2023-00072
• 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: 08/14/2023

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: 06/05/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2013
• 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: 59 YR
• Patient Sex: Male