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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problem Key or Button Unresponsive/not Working (4063)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2022
Event Type  malfunction  
Event Description
A distributor contacted heartsine to report that a customer¿s device was not responding to on/off button presses.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
 
Manufacturer Narrative
Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
 
Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault as upon receipt the device was found to be unable to be powered off via the on/off button.This fault was attributed to corrosion on the membrane tail.The corrosion observed on the membrane tail, alongside the corrosion on the usb contact collars would indicate the device had been subject to storage outside of the indicated conditions.The device was scrapped by heartsine and the customer was provided with a replacement device.
 
Event Description
A distributor contacted heartsine to report that a customer¿s device was not responding to on/off button presses.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
 
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Brand Name
PACKAGE,350P,PP03,INTL EN,350-BAS-UK-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 Key15234409
MDR Text Key305362356
Report Number3004123209-2022-00123
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeSN
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 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2022
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-BAS-UK-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received09/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2015
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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