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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03, UK, 350-STR-UK-10; AUTOMATED EXTERNAL DEFIBRILLATORS
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HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03, UK, 350-STR-UK-10; AUTOMATED EXTERNAL DEFIBRILLATORS Back to Search Results
Model Number 350P
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2023
Event Type  malfunction  
Manufacturer Narrative
Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
 
Event Description
The customer contacted heartsine to report that their device would not power on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Heartsine evaluated the customer's device and verified the reported issue.Heartsine observed that the device had a severe crack to the lower case assembly.Upon opening the device, damage was found on several components.Due to the extent of the damage to multiple components and circuitries, no further investigation could be carried out.Heartsine determined that the cause of the reported issue was due to impact damaged caused by the user.The returned device was scrapped by heartsine and the customer received a replacement device.
 
Event Description
The customer contacted heartsine to report that their device would not power on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
 
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Brand Name
PACKAGE, 350P, PP03, UK, 350-STR-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
brian blakeslee
207 airport road west
belfast BT3 9-ED
EI   BT3 9ED
4258674577
MDR Report Key18138306
MDR Text Key328127366
Report Number3004123209-2023-00163
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/18/2024
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-UK-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2023
Initial Date Manufacturer Received 10/26/2023
Initial Date FDA Received11/15/2023
Supplement Dates Manufacturer Received01/15/2024
Supplement Dates FDA Received01/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2015
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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