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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR

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HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number SAM
Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)
Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2017
Event Type  malfunction  
Event Description
Pad unit had low battery during usage.
 
Manufacturer Narrative
(b)(4). The device history records for the returned sam 350p device were reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed prior to the dispatch of the sam 350p from heartsine technologies, (b)(4) on (b)(6) 2016. The history log for this device showed that the pad-pak was first installed on (b)(6) 2016 and had performed to specification, alongside random manual power ons, up to and including the last log entry on the (b)(6) 2017. During the above period, the device was reported as being used in an sca on the (b)(6) 2017. There were 3 very short events. They appear to be simulated tests. The events were recorded on: (b)(6) 2016. A fourth patient event occurred on (b)(6) 2017. The event was 11 minutes 56 seconds. The patient did not have a shockable rhythm throughout. The event appeared to be sinus rhythm. A shock was not delivered but due to electrode artefact the algorithm reanalysed for a few seconds to ensure there was no shockable rhythm present. Chest compressions were administered intermittently at varying rates from around 120 cpm to 132 cpm. The electrodes appeared to become disconnected or removed at 4 minutes 53 seconds and there was no viewable ecg for the remainder of the event. During the time that an ecg was available for analysis it can be concluded that the device algorithm performed to specification. The user also pressed the on/off button on the device on a number of occasions towards the end of the event and on each occasion the device warned the user that the on/off button had been pressed. This is a failsafe mechanism in the device to warn the user that the on/off button may have been pressed unintentionally. The user then removed the pad-pak from the device in order to shut it down however the device was unable to enter the shutdown sequence and logged the pad-pak removal as a low battery in the memory log.
 
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Brand NameHEARTSINE SAMARITAN 350P AND PAD PAK
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
canberra house
203 airport road west
belfast, northern ireland BT3 9 ED
UK BT3 9ED
Manufacturer (Section G)
HEARTSINE TECHNOLOGIES LTD
canberra house
203 airport road west
belfast, northern ireland BT3 9 ED
UK BT3 9ED
Manufacturer Contact
james mcguinness
canberra house
203 airport road west
belfast, northern ireland BT3 9-ED
UK   BT3 9ED
4289093941
MDR Report Key6398623
MDR Text Key70027679
Report Number3004123209-2017-00210
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Patient
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSAM
Device Catalogue Number350P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/15/2017
Device Age1 YR
Event Location No Information
Date Report to Manufacturer03/09/2017
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/13/2017 Patient Sequence Number: 1
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