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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2022
Event Type  malfunction  
Event Description
A distributor contacted heartsine to report that a customer¿s device was providing voice prompts in a different language.This may lead to an inability understanding how to use the device correctly, which could prevent or delay defibrillation therapy.There was no report of patient use associated to the reported event.
 
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 providing voice prompts in a different language.This may lead to an inability understanding how to use the device correctly, which could prevent or delay defibrillation therapy.There was no report of patient use associated to the reported event.
 
Manufacturer Narrative
The prompt translations were sent to the translators (cpsl - language services) with the suggested changes by the thai distributor and the response was as follows: "according to our linguist, in most of the cases, the former translations are expressed in layman terms, which are simple language anyone can understand, while the ones from their distributor are more formal.The differences are not major but preferential issues in our opinion." the device was not returned.Stryker belfast determined no further action would be required.H3 other text : device not returned.
 
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Brand Name
PACKAGE,350P,PP03,USB,TH,350-BAS-TH-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 Key15480343
MDR Text Key306255349
Report Number3004123209-2022-00139
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeTH
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 11/02/2022
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-TH-10
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/01/2022
Initial Date FDA Received09/24/2022
Supplement Dates Manufacturer Received10/06/2022
Supplement Dates FDA Received11/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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