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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,FR,350-BAS-FR-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,FR,350-BAS-FR-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) 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 01/12/2024
Event Type  malfunction  
Event Description
The customer contacted stryker to report that their device power button would not work.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 continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
The customer contacted stryker to report that their device power button would not work.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's investigation of the device confirmed the reported fault as upon receipt the device was found to be unable to switch on.This fault was attributed to membrane failure due to insect inhabitancy within the device.During the investigation, short circuits were discovered on the membrane tail.A visual inspection revealed insects present across the membrane tail.The fault could not be replicated with a known good membrane fitted.The device was scrapped by heartsine and the customer was provided with a replacement device.
 
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Brand Name
PACKAGE,350P,PP03,FR,350-BAS-FR-10
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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 Key18564862
MDR Text Key333495298
Report Number3004123209-2024-00010
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeRE
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 04/04/2024
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-BAS-FR-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 01/12/2024
Initial Date FDA Received01/23/2024
Supplement Dates Manufacturer Received03/08/2024
Supplement Dates FDA Received04/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
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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