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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problems Failure to Power Up (1476); No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2023
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 did not emit audio prompts upon start up.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no report of 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 corrosion on the membrane tail due to being stored outside of indicated conditions.The device was scrapped by heartsine and the customer was provided with a replacement device.
 
Event Description
The customer contacted heartsine to report that their device did not emit audio prompts upon start up.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no report of patient use associated with the reported event.
 
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Brand Name
PACKAGE, 350P,PP03J,JA,350-STR-JA-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
brian blakeslee
207 airport road west
belfast BT3 9-ED
EI   BT3 9ED
4258674577
MDR Report Key18244020
MDR Text Key329450033
Report Number0003015876-2023-02257
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeJA
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 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2023
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-JA-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2020
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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