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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 DEFIBRILLATORS
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HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATORS 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 04/27/2023
Event Type  malfunction  
Event Description
The distributor contacted heartsine to report that the on/off button of a customer's device no longer worked.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with the reported 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 evaluated the customer's device and verified the reported issue.Heartsine determined that the cause of the reported issue was corrosion within the membrane panel, on the on/off button contact pads.The corrosion is indicative that the device had been stored outside the indicated conditions.The customer received a replacement device and the returned device scrapped by heartsine.
 
Event Description
The distributor contacted heartsine to report that the on/off button of a customer's device no longer worked.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with the reported event.
 
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Brand Name
PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS
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
dara friedman
207 airport road west
belfast BT3 9-ED
EI   BT3 9ED
4258674577
MDR Report Key16951138
MDR Text Key315446026
Report Number3004123209-2023-00054
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 Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/28/2023
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-BAS-UK-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 04/27/2023
Initial Date FDA Received05/18/2023
Supplement Dates Manufacturer Received07/07/2023
Supplement Dates FDA Received07/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2019
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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