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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 Appropriate Term/Code Not Available (3191); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  malfunction  
Event Description
Memory is full.No patient involved.
 
Manufacturer Narrative
Device stored outside of the indicated conditions.Upon receipt, the device issued ¿memory full¿, prompts with a memory capacity displayed at 12 % within saverevo.The memory capacity display in saverevo represents the total ecg/icg memory used by the device and therefore corresponds to the total recording time of the device since installation.Information from the device memory showed 91 log entries which include 57 occasions in which the device was stored below the indicated minimum and 34 manual power cycles, mainly under 1-minute duration.A low of -5.3 °c was recorded on the (b)(6) 2019.
 
Event Description
Memory is full.No patient involved.
 
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Brand Name
UNKNOWN_MEDICAL - BELFAST_PRODUCT
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
EI  BT3 9ED
MDR Report Key11391335
MDR Text Key238619121
Report Number3004123209-2021-00067
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 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer03/08/2021
Initial Date Manufacturer Received 02/16/2021
Initial Date FDA Received03/01/2021
Supplement Dates Manufacturer Received04/20/2021
Supplement Dates FDA Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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