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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE 360P, 1X PAD-PAK-03, FRENCH, 360-STR-FR-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE 360P, 1X PAD-PAK-03, FRENCH, 360-STR-FR-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number 360-STR-FR-10
Device Problem Failure to Shut Off (2939)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Event Description
Device will not switch off.No patient involvement.
 
Manufacturer Narrative
Upon receipt, the device would continuously rest after the device emitted an audible beep when powered on via the on/off button and could only be powered off by removal of the pad-pak, as per the reported fault.This was attributed to a short circuit fault on the returned speaker, which had resulted in an intermittent load on the 3.3 v line, causing the device to periodically reset when powered on.The device performed test shocks as required during investigation indicating its ability to deliver therapy was unaffected by this malfunction.
 
Event Description
Device will not switch off.No patient involvement.
 
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Brand Name
PACKAGE 360P, 1X PAD-PAK-03, FRENCH, 360-STR-FR-10
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 Key11628489
MDR Text Key246095515
Report Number3004123209-2021-00115
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number360-STR-FR-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
Date Manufacturer Received06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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