MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 360-BAS-UK-10

Device Problems Defective Device (2588); Audible Prompt/Feedback Problem (4020)

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

Event Date 07/08/2021

Event Type  malfunction  

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 may lead to a delay in defibrillation, which could cause an adverse event.Patient involved, no adverse consequences reported.

Manufacturer Narrative

Heartsine's investigation of the device could not confirm the reported fault as the sam 360p device performed to specification throughout the investigation.The device delivered the full shock therapy sequence without fault, with the returned pad-pak, during testing and was confirmed to record ecg data accurately without noise or other abnormalities.It is possible that the reported failure of the device to progress beyond ¿apply pads¿ prompts was due to the electrode pads not being removed from their liner, thus no connection to patient.There was evidence of the returned pads not being removed from their liner observed during the investigation.

Event Description

Complaint alleges to a device malfunction which may lead to a delay in defibrillation, which could cause an adverse event.Patient involved, no adverse consequences reported.

• Brand Name: PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 12201598
• MDR Text Key: 264930298
• Report Number: 3004123209-2021-00188
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 360-BAS-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1