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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR

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HEARTSINE TECHNOLOGIES LTD PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number 500-BAS-UK-10
Device Problems Electrical /Electronic Property Problem (1198); No Audible Prompt/Feedback (2282); Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2020
Event Type  malfunction  
Event Description
No sound or light prompts upon insertion of new pad-pak. No patient involved.
 
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Brand NamePACKAGE,500P,PP03,INTL EN,500-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 Key10716919
MDR Text Key213937263
Report Number3004123209-2020-00333
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number500-BAS-UK-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2020
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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