• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number SAM
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Death (1802); Patient Problem/Medical Problem (2688)
Event Date 09/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device history records for the returned sam 300p 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 300p from heartsine technologies, belfast on the 13th june 2011. The history log for this device showed that the pad-pak was first installed on (b)(6) 2011 and that it had performed to specification up to (b)(6) 2017. On (b)(6) 2017, the device was reported as being used in an sca event. During the investigation, the electrode pads were removed and replaced with test plugs. The device was tested on the calibrated defibrillator and delivered a test shock without fault. The device powered off with no warnings given and a flashing green status led. The electrode pads were detected as being attached approximately 1 minute and 57 seconds into the event. There were several occasions during the event when the patient's impedance went in and out of range the devices ability to measure multiple impedances accurately was tested during the investigation with no fault found. An in-range patient impedance was detected prior to the "check pads" message, which would suggest the electrode pads had initially been correctly attached. The variation in patient impedance may have been caused by pad positioning or the presence of conductive material. The electrode pads would need to make a direct gel to gel contact or have an alternative conductive component in-line, in order to achieve an impedance below 20[?]. Therefore, in the absence of the patient, the investigation is unable to replicate the reported fault.
 
Manufacturer Narrative
(b)(4).
 
Event Description
There was a patient involved in this event. The device had a fault message during usage. Apply pads prompt during event. The patient did not survive.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTSINE SAMARITAN 300P 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
MDR Report Key6867895
MDR Text Key250918975
Report Number3004123209-2017-01121
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 user facility
Reporter Occupation Patient
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/14/2017,10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSAM
Device Catalogue Number300P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/05/2017
Device Age6 YR
Event Location No Information
Date Report to Manufacturer09/14/2017
Date Manufacturer Received09/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2011
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: 09/15/2017 Patient Sequence Number: 1
-
-