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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03, ES, 350-STR-ES-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03, ES, 350-STR-ES-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2022
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
A distributor contacted heartsine to report that a customer¿s device was emitting inaudible voice prompts.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's investigation of the device confirmed the reported fault upon receipt, the advisory prompts being emitted were barely audible.The reported fault was attributed to membrane failure due to storage outside of the indicated conditions.The debris in the speaker housing would suggest the device had been stored in the presence of metallic particles.Due to the magnetic nature of the speaker, these particles would have been attracted through the holes of the speaker housing from the surrounding environment.The fault could not be replicated after clearing the metal particles from the speaker.This confirmed a failure of the speaker due to the ingress of metal particles.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 emitting inaudible voice prompts.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, ES, 350-STR-ES-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 Key15465220
MDR Text Key306183413
Report Number3004123209-2022-00138
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeSP
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 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2022
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-STR-ES-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received11/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2016
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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