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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 Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device history records for the returned sam 350p device was reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed prior to the despatch of the sam 350p from heartsine technologies, belfast on the 24th of december 2013. The history log for this device showed that the pad-pak was first installed on (b)(6) 2014 and performed all self-tests up to and including the last log entry on (b)(6) 2016. There were five manual power ups, of ten minutes' duration, observed in the device memory on (b)(6) 2016. The device successfully performs all weekly auto self-tests between the 10th of july 2016 and the 30th of april 2017. On (b)(6) 2017, the device failed the weekly auto self-test due to low battery. The device records two log entries of nonsensical duration and nonsensical data on (b)(6) 2017. No further log entries were recorded prior to receipt at heartsine. The returned pad-pak was disassembled to investigate and the battery cells were measured individually. Five of the cells showed similar depletion while the remaining cell was found to be significantly more depleted than the others. The returned pad-pak dhr was investigated showing it was 1 of (b)(4) pad-pak's manufactured under lot b1007, (b)(4) of which were sent to hst inc on the 20th of august 2014. All pad-pak's were subjected to a battery voltage test with no recorded fails. This would indicate the returned pad-pak became depleted after dispatch from heartsine. The device was tested on the calibrated defibrillator on the 10th of july 2017 and the device delivered a test shock without fault. The investigation found the fault can be attributed to a faulty battery cell in the returned pad-pak. The pad-pak, which contains the electrodes and batteries, is labelled for single use but the samaritan pad 300 and 300p devices are for multi-use.
 
Manufacturer Narrative
(b)(4). Device not yet returned to manufacturer.
 
Event Description
There was no patient involved in this event. Red status indicator. Pad-pak expiry 10/2018.
 
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Brand NameHEARTSINE SAMARITAN 350P AND PAD PAK
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast, united kingdom BT3 9 ED
UK BT3 9ED
Manufacturer (Section G)
HEARTSINE TECHNOLOGIES LLC - 2032757 - IMPORTER
mr. james mcguinness
121 friends lane, suite 400
newton PA 18940
Manufacturer Contact
james mcguinness
manufacturer
203 airport road west
belfast, northern ireland BT3 9-ED
UK   BT3 9ED
4289093941
MDR Report Key6600375
MDR Text Key250809210
Report Number3004123209-2017-00550
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P16008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Patient
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/30/2017,08/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSAM
Device Catalogue Number350P
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/23/2017
Device Age41 YR
Event Location No Information
Date Report to Manufacturer05/30/2017
Date Manufacturer Received05/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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