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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number SAM 350P
Device Problems Failure to Power Up (1476); No Audible Prompt/Feedback (2282); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Event Description
Red status led and beep.Device will not power off and is not providing voice prompts.No patient involvement.
 
Event Description
Red status led and beep.Device will not power off and is not providing voice prompts.No patient involvement.
 
Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault was attributed to membrane failure as a result of insect inhabitancy within the device.The device was capable of delivering shock therapy during testing.
 
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Brand Name
PACKAGE, 350P,PP03J,JA,350-STR-JA-10
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
EI  BT3 9ED
MDR Report Key11442551
MDR Text Key240358363
Report Number3004123209-2021-00091
Device Sequence Number1
Product Code MKJ
UDI-Device IdentifierM727SAM350P
UDI-PublicM727SAM350P
Combination Product (y/n)N
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSAM 350P
Device Catalogue Number350-STR-JA-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2021
Date Manufacturer Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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