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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS NEURO INCORPORATED NICONE; NIC1 C64 NOR W/ CBL HOLDER
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NATUS NEURO INCORPORATED NICONE; NIC1 C64 NOR W/ CBL HOLDER Back to Search Results
Model Number 515-004400
Device Problem Use of Device Problem (1670)
Patient Problem Burn(s) (1757)
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Determined probable root cause is use of c64 amplifier with inadequate grounding of the cardiac ablation system.
 
Event Description
Patient experienced electrode burns.
 
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Brand Name
NICONE
Type of Device
NIC1 C64 NOR W/ CBL HOLDER
Manufacturer (Section D)
NATUS NEURO INCORPORATED
3150 pleasant view road
middleton WI 53562
Manufacturer (Section G)
NATUS NEUROLOGY INCORPORATED
3150 pleasant view road
middleton WI 53562
Manufacturer Contact
janessa boone
3150 pleasant view road
middleton, WI 53562
6088298603
MDR Report Key8739235
MDR Text Key149344629
Report Number3010611950-2019-00041
Device Sequence Number1
Product Code GWQ
UDI-Device Identifier00382830037853
UDI-Public00382830037853
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K964280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number515-004400
Device Catalogue Number515-004400
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient Weight61
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