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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number SAM 350P
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/26/2021
Type of Reportable Event Malfunction
Event or Problem Description
Red status led and device service prompt.No patient involvement.
 
Additional Manufacturer Narrative
The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time; if the device is returned to the manufacturer the investigation will be reopened.
 
Event or Problem Description
Red status led and device service prompt.No patient involvement.
 
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Brand Name
PACKAGE,350P,PP01,EN,350-STR-US-10
Common Device Name
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
EI  BT3 9ED
MDR Report Key11782085
Report Number3004123209-2021-00140
Device Sequence Number17136985
Product Code MKJ
UDI-Device IdentifierM727SAM350P
UDI-PublicM727SAM350P
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P160008
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/06/2021
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
Operator of Device No Information
Device Model NumberSAM 350P
Device Catalogue Number350-STR-US-10
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/26/2021
Supplement Date Received by Manufacturer06/14/2021
Initial Report FDA Received Date05/06/2021
Supplement Report FDA Received Date07/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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