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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

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HEARTSINE TECHNOLOGIES LTD PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number 500-BAS-UK-10
Device Problems Labelling, Instructions for Use or Training Problem (1318); Output Problem (3005); Audible Prompt/Feedback Problem (4020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  malfunction  
Manufacturer Narrative
The returned device will be investigated by heartsine.Upon conclusion of the investigation a follow up report will be submitted detailing the findings.
 
Event Description
Child prompts with adult pad-pak has the potential to cause adverse event.No patient was involved in this event.
 
Event Description
Child prompts with adult pad-pak has the potential to cause adverse event.No patient was involved in this event.
 
Manufacturer Narrative
Heartsine's investigation confirmed the reported fault as the device was found to be giving incorrect child patient prompts with an adult pad-pak installed.The investigation determined a failure of the reed switch which controls whether the device recognises an adult or child patient pad-pak insertion.If an child patient is detected but an adult is connected, the higher the impedance the lower the shock energy.There is potential to cause an adverse event but it is dependent on the impedance of the patient.
 
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Brand Name
PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10
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 Key12105859
MDR Text Key262077210
Report Number3004123209-2021-00173
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 08/27/2021
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 Number500-BAS-UK-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Initial Date Manufacturer Received 06/15/2021
Initial Date FDA Received07/02/2021
Supplement Dates Manufacturer Received08/24/2021
Supplement Dates FDA Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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