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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NEUROWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDEO
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NATUS MEDICAL INCORPORATED NEUROWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDEO Back to Search Results
Model Number LC101-9
Device Problem Sparking (2595)
Patient Problem Cardiac Arrest (1762)
Event Date 02/07/2024
Event Type  Death  
Manufacturer Narrative
Initial report ref natus complaint #: (b)(4).7-feb-2024: the customer inquired if natus has guidelines/recommendations for use of ltm eeg carts in patients undergoing defibrillation as part of advanced cardiac life support.Our eeg devices should not be used with defibrillators as stated in our ifu warnings.The customer was advised that "due to the voltages and amperage created by the defibrillator, it could cause damage to the eeg equipment.Page 19 of the eeg32u user and service manual (105491 rev q), warning "the eeg32u system is not designed to work with defibrillators.The system could be damaged when used with this device." page 17 of the natus quantum (phase ii) user and service manual (023145 rev 07) warning "the quantum amplifier system is not designed to work with defibrillators.The system could be damaged when used with this device." we believe this would be the case with electrodes as well, they should not be used on a patient when defib is in process.If there is current from the defibrillator, sparks can occur.An adverse event questionnaire has been sent to the customer.Install date: 22-oct-2020.Risk review: per doc-010378 rev 69 xltek eeg psg ras.Hazard 5.14 - emi susceptibility to defibrillation results in inability to collect data.Cause (harm) - clinically insignificant to delayed diagnosis.Rba rating: low.The hazards identified have been evaluated and found to be in compliance with a known standard.As noted in qms-000018, hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistent with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.Risk outweighed by benefit of use of device.
 
Event Description
Neuroworks 9.X acquisition software with spike / event and high res video: a report of a patient (who ultimately expired) who underwent defibrillation as part of a code blue while being monitored by ceeg (not sure which amplifier type).Reportedly the code team unplugged the eeg cart and during defib there were sparks between electrodes.
 
Manufacturer Narrative
Follow up report 001 ref natus complaint#(b)(4).The customer has not responded to any questions or communication sent by natus.The complaint received from the customer was a question regarding guidelines/recommendations for use of ltm eeg carts in patients undergoing defibrillation as part of advanced cardiac life support.The customer was unable to identify which devices were in use prior to defibrillation.The two devices that they may have been used are, quantum and eeg32u.The customer stated, the code team unplugged the eeg cart prior to defibrillation.The customer stated they believed a rhythmlink electrode (not a natus device) was used during the monitoring.Certain electrodes used with ecg monitors are designed to be compatible with defibrillation proof monitors so that they can resume data acquisition after stimulus and provide protection against leakage currents.It's not clear if these electrodes are labelled to be defibrillation proof or if the rhythmlink electrode was used.As example a typical warning may include; a residual charge will block acquisition of the ecg signal.Natus reviewed the ifus and risk management file regarding defibrillation with natus devices.Reference ifus below: quantum warning in ifu, 023415 page 16.Eeg32u warning in ifu, 105491 page 18.There is no specific failure mode as natus devices are not intended to be used with defibrillation devices.Natus eeg devices are not intended to be used with defibrillation devices as stated in our ifus.No medical device reports, or complaints related to this same problem/issue over the past two years.No related capas.Follow ups with the customer were completed 13-feb-2024, 16-feb-2024, 25-feb-2024, and 01-mar-2024 requesting additional information, and for them to return the adverse event questionnaire, but no response to date.
 
Event Description
Neuroworks 9.X acquisition software with spike / event and high res video: a report of a patient (who ultimately expired) who underwent defibrillation as part of a code blue while being monitored by ceeg (not sure which amplifier type).Reportedly the code team unplugged the eeg cart and during defib there were sparks between electrodes.
 
Event Description
Neuroworks 9.X acquisition software with spike / event and high res video: a report of a patient (who ultimately expired) who underwent defibrillation as part of a code blue while being monitored by ceeg (not sure which amplifier type).Reportedly the code team unplugged the eeg cart and during defib there were sparks between electrodes.
 
Manufacturer Narrative
Follow up report 002 ref natus complaint # (b)(4).No further follow up action has been recorded or cross referenced in the complaint record for at least 30 days since the customer's last conversation.The customer has not called back.Review of customer's account found no additional related calls.Complaint is now closed but may require future action if trending so prescribes.
 
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Brand Name
NEUROWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDEO
Type of Device
NEUROWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDEO
Manufacturer (Section D)
NATUS MEDICAL INCORPORATED
dba excel-tech ltd.
2568 bristol circle
oakville, ontarios, L6H 5 S1
CA  L6H 5S1
Manufacturer (Section G)
NATUS MANUFACTURING LIMITED
ida business park
gort
galway h91pd92,
EI  
Manufacturer Contact
gráinne walsh
dba excel-tech ltd.
2568 bristol circle
oakville, ontarios, L6H 5-S1
CA   L6H 5S1
MDR Report Key18682851
MDR Text Key335069156
Report Number9612330-2024-00012
Device Sequence Number1
Product Code OMB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberLC101-9
Device Catalogue NumberLC101-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
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