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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
Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Event Description
Low battery warning and beep with in date pad-pak.No patient involvement.
 
Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault, as the returned pad-pak was found to be severely depleted.Upon receipt, the device could not be powered on.These faults were attributed to moisture and corrosion within the device on multiple components and circuits.This had led to a constantly illuminated green status indicator alongside a flashing red status indicator on receipt at heartsine, which resulted in a high current drain and the subsequent depletion of the returned pad-pak.Inability to power the device on could result in adverse consequences, should it be used in a patient event.
 
Event Description
Low battery warning and beep with in date pad-pak.No patient involvement.
 
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Brand Name
PACKAGE,350P,PP01,EN,350-STR-US-10
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
207 airport road west
belfast BT3 9 ED
EI  BT3 9ED
MDR Report Key11824258
MDR Text Key254526453
Report Number3004123209-2021-00156
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 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
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-US-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2021
Date Manufacturer Received08/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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