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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 Problem Physical Resistance/Sticking (4012)
Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194)
Event Date 08/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
This was a patient involved event. A resident participating in therapy became light headed and hypotensive with blood pressure 60/40 and had a palpable pulse. The pads were applied and the device was turned on. During the event the device instructions allegedly stopped at "place the patches on the patient". A minute passed and the patches were removed and hands on cpr was started. The battery pack is dated 2021-09-01. The pads were sticky and were placed on the chest. There was little hair present. The patient survived to hospital admission.
 
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Brand NameHEARTSINE SAMARITAN 300P AND PAD-PAK
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
Manufacturer (Section G)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
Manufacturer Contact
caroline kirwan
203 airport road west
belfast BT3 9-ED
2890939400
MDR Report Key7887558
MDR Text Key120732944
Report Number3004123209-2018-00581
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K014067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_BEL
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0124-2013

Patient Treatment Data
Date Received: 09/18/2018 Patient Sequence Number: 1
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