HEARTSINE SAMARITAN 300P AND PAD-PAK UNK_BEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-25 for HEARTSINE SAMARITAN 300P AND PAD-PAK UNK_BEL manufactured by Heartsine Technologies Ltd.

Event Text Entries

[112360452] (b)(4). Device not received yet.
Patient Sequence No: 1, Text Type: N, H10


[112360453] There is no patient involved. Device prompting memory full.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004123209-2018-00416
MDR Report Key7633062
Date Received2018-06-25
Date of Report2018-07-03
Date of Event2018-06-11
Date Mfgr Received2018-06-27
Device Manufacturer Date2010-04-26
Date Added to Maude2018-06-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CAROLINE KIRWAN
Manufacturer Street203 AIRPORT ROAD WEST
Manufacturer CityBELFAST BT3 9ED
Manufacturer PostalBT3 9ED
Manufacturer Phone2890939400
Manufacturer G1HEARTSINE TECHNOLOGIES LTD
Manufacturer Street203 AIRPORT ROAD WEST
Manufacturer CityBELFAST BT3 9ED
Manufacturer Postal CodeBT3 9ED
Single Use3
Previous Use Code3
Removal Correction NumberZ-0124-2013
Event Type3
Type of Report0

Device Details

Brand NameHEARTSINE SAMARITAN 300P AND PAD-PAK
Generic NameAUTOMATED EXTERNAL DEFIBRILLATOR
Product CodeMJK
Date Received2018-06-25
Returned To Mfg2018-06-18
Catalog NumberUNK_BEL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHEARTSINE TECHNOLOGIES LTD
Manufacturer Address203 AIRPORT ROAD WEST BELFAST BT3 9ED BT3 9ED


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.