MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number UNK_BEL

Device Problems Therapeutic or Diagnostic Output Failure (3023); Audible Prompt/Feedback Problem (4020)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 08/11/2021

Event Type  Death  

Manufacturer Narrative

Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.

Event Description

Complaint alleges to a device malfunction which has led to a delay or prevention of patient defibrillation, resulting in adverse consequences.

Manufacturer Narrative

Heartsine's investigation of the device was unable to confirm the reported fault.During the investigation, no fault was found on the hdf-3500 or the returned pad-pak.The device delivered the full shock therapy sequence without fault with the returned pad-pak and electrodes during testing, and the device recorded ecg data accurately without noise or other abnormalities.

Event Description

Complaint alleges to a device malfunction which has led to a delay or prevention of patient defibrillation, resulting in adverse consequences.

• Brand Name: UNKNOWN_MEDICAL - BELFAST_PRODUCT
• 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: rebecca funston ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 2890939400
• MDR Report Key: 12381350
• MDR Text Key: 269232845
• Report Number: 3004123209-2021-00226
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K014067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

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: No Information
• Device Catalogue Number: UNK_BEL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 08/29/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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