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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD-PAK; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD-PAK; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number UNK_BEL
Device Problems Communication or Transmission Problem (2896); Audible Prompt/Feedback Problem (4020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2020
Event Type  malfunction  
Event Description
Adult pad pak is inserted and the device starting with: patient is a child.There was no patient involved in this event.
 
Manufacturer Narrative
The device history records for the sam 300p device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.The review revealed no rework was conducted and no concessions/deviations related to the issue were identified.The sam 300p passed ¿out qat from heartsine technologies on the 13th april 2011.A visual inspection of the device revealed no apparent defects.After further investigation it was found that the reported fault could be attributed to the failure of reed switch, sw1.The returned sam 300p is now outside of its warranty period and will be scrapped.
 
Event Description
Adult pad pak is inserted and the device starting with: patient is a child.There was no patient involved in this event.
 
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Brand Name
HEARTSINE SAMARITAN 300P 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 Key11146547
MDR Text Key227514289
Report Number3004123209-2021-00001
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K014067
Number of Events Reported1
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 Received01/11/2021
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 Manufacturer01/11/2021
Date Manufacturer Received02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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