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

Model Number 350P

Device Problem Failure to Deliver Energy (1211)

Patient Problems Ventricular Fibrillation (2130); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2023

Event Type  Death  

Manufacturer Narrative

The customer provided stryker 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 distributor contacted heartsine to request a replacement electrode/battery pack following device use.During a post-event data review, heartsine observed that the device may not have delivered a shock during a patient event.In this state, defibrillation therapy would not be available if needed.The patient associated with the reported event did not survive.

Event Description

The distributor contacted heartsine to request a replacement electrode/battery pack following device use.During a post-event data review, heartsine observed that the device may not have delivered a shock during a patient event.In this state, defibrillation therapy would not be available if needed.The patient associated with the reported event did not survive.

Manufacturer Narrative

A clinical review of the event found that the device twice stated a shock was delivered.However, in each instance a shock error was logged and the ecg trace does not contain a high amplitude transient impulse indicative of a shock deliver.The device was not returned to heartsine for evaluation.The cause of the reported issue could not be determined.H3 other text : not returned to manufacturer.

Event Description

The distributor contacted heartsine to request a replacement electrode/battery pack following device use.During a post-event data review, heartsine observed that the device may not have delivered a shock during a patient event.In this state, defibrillation therapy would not be available if needed.The patient associated with the reported event did not survive.

Manufacturer Narrative

Heartsine evaluated the customer's device and verified the issue observed from the electronic records of the device.Heartsine determined that the cause of the observed issue were due to transistors, designators q11 and q14.A review of the electronic records from the device showed that prior to the event on march 25th 2023, the customer had successfully delivered 6 shocks with the device.During the 7th and 8th shock the device logged voltage values of 0.This was attributed to a high voltage breakdown which had resulted in permanent damage to transistors q11 and q14.No further details are known for this event.The user would have been alerted to the failure with a ¿warning, device service required¿, prompt alongside a flashing red status indicator and failure chirp on shutdown after the first event.(the event prior to the event on march 25th 2023) however, the device was not removed from service prior to the second event, occurring on the 25th march 2023, when the voltage value of 0 was logged during the 2 shock attempts.The user would have again been alerted with a ¿warning, device service required¿, prompt on shutdown alongside a flashing red status indicator and failure chirp.The cause of the reported issue was due to transistors, designators q11 and q14, as well as user error.The user would have been alerted to remove the device from service did not do so.The device was scrapped by heartsine and the customer was provided with a replacement device.

• Brand Name: PACKAGE, 350P, PP03, ES, 350-STR-ES-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: 16900546
• MDR Text Key: 314883723
• Report Number: 3004123209-2023-00046
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 350P
• Device Catalogue Number: 350-STR-ES-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 06/06/2023; 09/20/2023
• Supplement Dates FDA Received: 06/09/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• 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 Outcome(s): Death
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG