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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR

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HEARTSINE TECHNOLOGIES LTD PACKAGE,360P,PP03,INTL EN,360-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number 360-BAS-UK-10
Device Problems Failure to Back-Up (1047); Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Event Description
Red/green status led flashing and memory full prompt. No patient involvement.
 
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Brand NamePACKAGE,360P,PP03,INTL EN,360-BAS-UK-10
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
EI BT3 9ED
Manufacturer (Section G)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
EI BT3 9ED
Manufacturer Contact
rebecca funston
203 airport road west
belfast BT3 9-ED
EI   BT3 9ED
2890939400
MDR Report Key11671608
MDR Text Key250412588
Report Number3004123209-2021-00128
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number360-BAS-UK-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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