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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03, PO, 350-STR-PO-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03, PO, 350-STR-PO-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Event Description
A distributor contacted heartsine to report that a customer¿s device was not able to be powered on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
 
Manufacturer Narrative
Heartsine has received the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
 
Event Description
A distributor contacted heartsine to report that a customer¿s device was not able to be powered on.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
 
Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault.The reported fault was attributed to impact damage from uses error.The device was scrapped by heartsine and the customer was provided with a replacement device.
 
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Brand Name
PACKAGE, 350P, PP03, PO, 350-STR-PO-10
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
207 airport road west
belfast BT3 9 ED
EI  BT3 9ED
Manufacturer (Section G)
HEARTSINE TECHNOLOGIES LTD
207 airport road west
belfast BT3 9 ED
EI   BT3 9ED
Manufacturer Contact
todd bandy
207 airport road west
belfast BT3 9-ED
EI   BT3 9ED
4258674577
MDR Report Key16036497
MDR Text Key308375378
Report Number3004123209-2022-00169
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number350P
Device Catalogue Number350-STR-PO-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2022
Date Manufacturer Received02/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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