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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PSA-NEMO, MANUAL, 4 AA BATTERIES; ACCESSORY
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ST. JUDE MEDICAL, INC. PSA-NEMO, MANUAL, 4 AA BATTERIES; ACCESSORY Back to Search Results
Model Number EX3100
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Information (3190)
Event Date 08/05/2018
Event Type  malfunction  
Manufacturer Narrative
Failure event observed during analysis.Final analysis revealed there was burn damage in the battery compartment.No batteries were received with the unit and internal visual inspection revealed no burn damage to the internal pcbas.
 
Event Description
This report is to advise of an event observed during analysis.
 
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Brand Name
PSA-NEMO, MANUAL, 4 AA BATTERIES
Type of Device
ACCESSORY
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7820738
MDR Text Key118425291
Report Number2017865-2018-11668
Device Sequence Number1
Product Code KRG
UDI-Device Identifier05414734503105
UDI-Public05414734503105
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEX3100
Device Catalogue NumberEX3100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Was the Report Sent to FDA? No
Date Manufacturer Received08/05/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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