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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 Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
 
Event Description
Complaint alleges that device did not operate as intended, this could prevent or delay defibrillation, which may result in adverse consequences.No patient involvement.
 
Manufacturer Narrative
Correction to initial report stating no patient impact.Additional information confirms event was patient involved, no impact to patient.Should further information be available before the investigation is complete another follow-up report shall be submitted.
 
Event Description
Complaint alleges that device did not operate as intended, this could prevent or delay defibrillation, which may result in adverse consequences.Patient involved- no impact.
 
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Brand Name
UNKNOWN_MEDICAL - BELFAST_PRODUCT
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
207 airport road west
belfast BT3 9 ED
EI  BT3 9ED
MDR Report Key12317819
MDR Text Key267970653
Report Number3004123209-2021-00200
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 08/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_BEL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Date Manufacturer Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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