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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 360P, PP03, UK, 360-STR-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR

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HEARTSINE TECHNOLOGIES LTD PACKAGE, 360P, PP03, UK, 360-STR-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number 360-STR-UK-10
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
Heartsine has requested return of the complaint device. Upon its receipt, the device will be investigated and a follow up report submitted within 30 days documenting the findings.
 
Event Description
Absence of voice prompts may lead to adverse consequences if device use is required. No patient involved in this event.
 
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Brand NamePACKAGE, 360P, PP03, UK, 360-STR-UK-10
Type of DeviceAUTOMATED 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
rebecca funston
207 airport road west
belfast BT3 9-ED
EI   BT3 9ED
2890939400
MDR Report Key12106032
MDR Text Key262166126
Report Number3004123209-2021-00175
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number360-STR-UK-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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