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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 Battery Problem (2885); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2020
Event Type  malfunction  
Event Description
Low battery.No patient involved.
 
Manufacturer Narrative
Information from the device memory indicated that the device had consistently been stored outside the indicated conditions and was manually powered on numerous times culminating in the memory becoming full and alerting the user.Additional low battery fails were indicated in the memory however investigation was unable to replicate these; they may be a consequence of temperature fluctuation, an incorrectly seated pad-pak or use of a pad-pak not returned for investigation.
 
Event Description
Low battery.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 Key11280509
MDR Text Key231317821
Report Number3004123209-2021-00025
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 04/08/2021
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 Manufacturer02/08/2021
Initial Date Manufacturer Received 01/04/2021
Initial Date FDA Received02/04/2021
Supplement Dates Manufacturer Received03/30/2021
Supplement Dates FDA Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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