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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 Defective Device (2588); Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
Event Type  malfunction  
Event Description
Red status led and device service prompt.No patient involvement.
 
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 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
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 Key11782085
MDR Text Key251671607
Report Number3004123209-2021-00140
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 consumer
Type of Report Initial,Followup
Report Date 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
Device Operator No Information
Device Model NumberSAM 350P
Device Catalogue Number350-STR-US-10
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/26/2021
Initial Date FDA Received05/06/2021
Supplement Dates Manufacturer Received06/14/2021
Supplement Dates FDA Received07/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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