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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 Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2023
Event Type  malfunction  
Event Description
A distributor contacted heartsine to report that a customer¿s device did not progress past apply pads.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
 
Manufacturer Narrative
Heartsine contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Heartsine has received the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
 
Manufacturer Narrative
Heartsine evaluated the customer's device but was unable to duplicate the reported issue.There was no fault found with the device.No continuity issue was identified on the patient output cables and no fault found on the pogo pins that would have resulted in an impedance detection issue.The device accurately measured impedances throughout the specified range, even under the stress of elevated temperature.Given no fault found on the aed or returned pad-pak and no further information provided by the customer, the investigation was unable to determine how the reported fault could have occurred.It can only be suggested that this due to situational factors.E.G., a pad-pak fitment issue or incorrect placement of pads on the patient.The device was retained by heartsine.
 
Event Description
A distributor contacted heartsine to report that a customer¿s device did not progress past apply pads.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
 
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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 Key16551392
MDR Text Key311382769
Report Number3004123209-2023-00025
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 Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/24/2023
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 Manufacturer03/06/2023
Initial Date Manufacturer Received 02/23/2023
Initial Date FDA Received03/16/2023
Supplement Dates Manufacturer Received03/28/2023
Supplement Dates FDA Received04/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2019
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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