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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,1X PAD-PAK-03, DUTCH, 350-STR-NL-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,1X PAD-PAK-03, DUTCH, 350-STR-NL-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problems Defibrillation/Stimulation Problem (1573); Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2022
Event Type  malfunction  
Event Description
A distributor contacted heartsine to report that a customer¿s device was providing child patient prompts with an adult pad-pak.As patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient.As a result, wrong defibrillation therapy may be delivered.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 providing child patient prompts with an adult pad-pak.As patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient.As a result, wrong defibrillation therapy may be delivered.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 receipt the device found to be giving incorrect child patient prompts with an adult pad-pak installed, as per the reported fault.This fault was attributed to a reed switch failure.The device was scrapped by heartsine and the customer was provided with a replacement device.
 
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Brand Name
PACKAGE, 350P,1X PAD-PAK-03, DUTCH, 350-STR-NL-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 Key15175491
MDR Text Key304974113
Report Number3004123209-2022-00118
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeNL
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 08/31/2022
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 Lay User/Patient
Device Model Number350P
Device Catalogue Number350-STR-NL-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2022
Initial Date Manufacturer Received 07/15/2022
Initial Date FDA Received08/05/2022
Supplement Dates Manufacturer Received08/11/2022
Supplement Dates FDA Received08/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2015
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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