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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 Unintended Power Up (1162); Self-Activation or Keying (1557)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Event Description
Device switching on automatically.No patient involvement.
 
Manufacturer Narrative
Device serial provided by complainant on 13 may 2021.Serial number is (b)(6).
 
Event Description
Device switching on automatically.No patient involvement.
 
Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault, as upon receipt the device was witnessed to be switching on automatically.The fault was attributed to membrane corrosion, which caused a leak between tracks within the membrane, causing the device to switch on automatically.The membrane failure was root caused to the device being subject to storage outside of the indicated conditions.A device powering up automatically will not prevent delivery of shock therapy, and the device was capable of providing a test shock during testing.
 
Event Description
Device switching on automatically.No patient involvement.
 
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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 Key11768696
MDR Text Key251446124
Report Number3004123209-2021-00130
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 consumer
Type of Report Initial,Followup,Followup
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2021
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 Manufacturer07/26/2021
Date Manufacturer Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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