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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2022
Event Type  malfunction  
Manufacturer Narrative
Heartsine has received the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
 
Event Description
The distributor contacted heartsine to report that their device may not be providing sufficient voice prompts.Absence of voice prompts may lead to an inability understanding how to use the device correctly.This could result in adverse consequences.There was no report of patient use associated to the reported event.
 
Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault as upon receipt the device was found to be emitting audio prompts that were barely audible.This fault was attributed to adverse storage of the device.The device was scrapped by heartsine and the customer was provided with a replacement device.
 
Event Description
The distributor contacted heartsine to report that their device may not be providing sufficient voice prompts.Absence of voice prompts may lead to an inability understanding how to use the device correctly.This could result in adverse consequences.There was no report of patient use associated to the reported event.
 
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Brand Name
PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-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 Key15916512
MDR Text Key308172999
Report Number3004123209-2022-00159
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/03/2023
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-STR-ST-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2022
Initial Date Manufacturer Received 11/16/2022
Initial Date FDA Received12/05/2022
Supplement Dates Manufacturer Received01/09/2023
Supplement Dates FDA Received02/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2014
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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