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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problem Failure to Deliver Shock/Stimulation (1133)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2022
Event Type  malfunction  
Event Description
The distributor contacted heartsine to report that their device does not give a shock during testing.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 technologies ltd has requested the return of the device from the distributor in order to investigate the alleged malfunction.Upon completion, the conclusions will be submitted in a follow-up report.
 
Event Description
The distributor contacted heartsine to report that their device does not give a shock during testing.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 as upon return the device was unable to deliver a shock.The reported fault was attributed to a failed capacitor, which forms part of the switching circuitry used to deliver phase one of shock delivery.The device was scrapped by heartsine and the customer was provided with a replacement device.D2 update: due to new fda approval for this model, the product code has been updated from mkj to nsa.
 
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Brand Name
PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-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 Key14436996
MDR Text Key292041996
Report Number3004123209-2022-00075
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2022
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-ST-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received07/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2016
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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