MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 500-BAS-UK-10

Device Problems No Audible Prompt/Feedback (2282); Audible Prompt/Feedback Problem (4020)

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

Event Date 11/11/2020

Event Type  malfunction  

Event Description

When turned on, emits the sounds at a very low volume.There was no patient involved in this event.

Manufacturer Narrative

The device history records for the sam 500p device was reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed.The review revealed no rework was conducted and no concessions/deviations related to the issue were identified.The sam 500p passed ¿out qat¿ from heartsine technologies on the 23rd may 2013.Visual inspection of the device revealed dirt on the outer casings, including around the speaker housing on the upper case.This would indicate the device had been stored outside of the indicated conditions.After further investigation it was found that the reported fault could be attributed to ingress of debris onto the speaker, due to storage outside of the indicated conditions.Contributing to the device emitting low volume from the speaker, as per the reported fault.It is a policy of heartsine to not refurbish devices that have been returned from the field, therefore this device shall be scrapped and replaced with a sam 500p.

Event Description

When turned on, emits the sounds at a very low volume.There was no patient involved in this event.

• Brand Name: PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 10883104
• MDR Text Key: 218257303
• Report Number: 3004123209-2020-00366
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 500-BAS-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1