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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT AUTOMATED EXTERNAL DEFIBRILLATOR

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HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number UNK_BEL
Device Problems Failure to Deliver Shock/Stimulation (1133); Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
Return of the device has been requested by heartsine to investigate the reported fault. A supplemental mdr will be submitted following completion of investigation.
 
Event Description
Device used on a patient on (b)(6) 2021. Device reported to not have worked and 'did not give a pulse'. Customer review of the event indicated the message "test failed - communication error". No adverse event was reported by the complainant.
 
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Brand NameUNKNOWN_MEDICAL - BELFAST_PRODUCT
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 Key11900266
MDR Text Key256163965
Report Number3004123209-2021-00164
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K014067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_BEL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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