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

Model Number SAM350P

Device Problem Failure to Sense (1559)

Patient Problem Cardiac Arrest (1762)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

The customer contacted heartsine to report that their device did not detect the patient when the defibrillation pads were applied.In this state the device would not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.There has been no alleged device contribution to the patient outcome.

Manufacturer Narrative

Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow up report.The customer provided heartsine with the available patient information.Patient fields in which information is not provided were intentionally left blank.

Manufacturer Narrative

Heartsine has made multiple attempts to contact the customer regarding the status of their device, but no response has been received from the customer.The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time.The cause of the reported issue could not be determined.If the device is returned to the manufacturer the investigation will be reopened.

Event Description

The customer contacted heartsine to report that their device did not detect the patient when the defibrillation pads were applied.In this state the device would not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.There has been no alleged device contribution to the patient outcome.

Event Description

The customer contacted heartsine to report that their device did not detect the patient when the defibrillation pads were applied.In this state the device would not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.There has been no alleged device contribution to the patient outcome.

Manufacturer Narrative

Heartsine's investigation of the device was unable to confirm the reported fault.Throughout the investigation, the device performed to specification.Four manual power ons of up to 4-minute duration were recorded on the day of the reported event.During these power-ons the device did not detect an in-range impedance and therefore did not progress to analyse or advise a shock.As no fault could be found with the device, the failure has been attributed to a potential use error.The device was scrapped by heartsine and the customer was provided with a replacement device.

• 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: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 18400550
• MDR Text Key: 331419615
• Report Number: 3004123209-2023-00179
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2024

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: SAM350P
• Device Catalogue Number: 350-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 02/28/2024; 04/19/2024
• Supplement Dates FDA Received: 03/14/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2022
• 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 Outcome(s): Death
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White