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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HDF3500 AND PAD-PAK; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD HDF3500 AND PAD-PAK; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number UNK_BEL
Device Problems Electrical /Electronic Property Problem (1198); Image Display Error/Artifact (1304)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2020
Event Type  malfunction  
Event Description
The standby display was red.There was no patient involved in this event.
 
Manufacturer Narrative
The device history records for the hdf-3500 device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.The hdf-3500 passed ¿out qat from heartsine technologies on the 2nd august 2017.Unable to confirm the reported fault.The device was reported to have issued a flashing red status indicator.Throughout the investigation, the green status led flashed as normal and the red status led did not illuminate outside of specification.Information from the device memory showed the device failed no self-tests, which is the normal condition required to activate the red status indicator.It is a policy of heartsine to not refurbish devices that have been returned from the field, therefore this device shall be retained and replaced with a new hdf-3500.
 
Event Description
The standby display was red.There was no patient involved in this event.
 
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Brand Name
HDF3500 AND PAD-PAK
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 Key10458743
MDR Text Key204920516
Report Number3004123209-2020-00275
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Replace
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_BEL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Date Manufacturer Received08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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