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U.S. Department of Health and Human Services

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

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HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
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.
 
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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 Key12381350
MDR Text Key269232845
Report Number3004123209-2021-00226
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K014067
Number of Events Reported1
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 NumberUNK_BEL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/18/2021
Initial Date FDA Received08/29/2021
Supplement Dates Manufacturer Received09/13/2021
Supplement Dates FDA Received09/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
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