MAUDE Adverse Event Report: NATUS NEUROLOGY INCOPORATED CNS DEVICE INTERFACE NEUROPTICS NPI-200 PUPILLOMETER

Model Number CAB-221

Device Problems Crack (1135); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

Initial report ref natus complaint#: (b)(4).The cns-eeg-300 was used with cable 103-0076 rev.B.Customer provided pictures of the affected parts.Per cns-ha-001-01 cns monitor hazard analysis, hazard id - pe-05, severity - negligible, the risk is considered acceptable.Udi number to be confirmed.Further investigation to be carried out.

Event Description

Cns-eeg-300 advanced icu amplifier - the customer reported that the amplifier box has minor cracks on the top and bottom of the case.The customer also reported that the amplifier cable causes false gdp (seizure) waveforms.No injuries.

Manufacturer Narrative

Follow up report 002 ref natus complaint#(b)(4).Per cns-ha-001-01 cns monitor hazard analysis, hazard id: d-09, severity - negligible, the risk is considered acceptable.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.The question was asked how the neuroptics pupillometer smartguard readers could cause the seizure like activity/gpd, and it was noted that older readers (omnikey 5421) emit electromagnetic radiation that gets picked up by the amplifier and appears in the eeg when the reader is physically near the amplifier/electrodes.The new smart readers that are currently sold do not cause such interference.Technical service were asked to confirm if for this complaint the cable is an order version.It was confirmed that the cable has always been numbered cab-221 in our system, but the manufacture, part number changed from omnikey 5421 to omnikey 5022 a few years ago.Omnikey 5421 is the older manufactured part."alternate ots component source approval" document shows that the manufacture of the smart guard reader, discontinued the omnikey 5421 smart guard reader in 2019.This led to use of the new smart reader omnikey 5022.The seizure like activity reported by the customer was caused by an old smart guard reader - manufacture part number omnikey 5421.The smart guard reader, manufacture part omnikey 5421, was discontinued by the manufacture in 2019 and replaced with the smart guard reader, manufacturer part number omnikey 5022.The new smart guard reader does not cause the interference reported by the customer.Failure confirmed: yes.Investigation result code: neuro sbu|artifact.Closure rationale: complaint verified, being tracked as a trend.Complaint will be included in trending data for further review.

Event Description

Part cab-221 cns device interface neuroptics npi-200 pupillometer - the customer reported that the amplifier cable causes false gdp (seizure) waveforms.No injuries.

Event Description

The customer reported that the amplifier box has minor cracks on the top and bottom of the case - related to 3010611950-2023-00001 (amplifier cable causes false gdp (seizure) waveforms).No injuries.

Manufacturer Narrative

Follow up report 001 ref natus complaint#(b)(4).Correction to sections b5, d1, d2 ,d4, (affected part was confirmed to be - part cab-221 cns device interface neuroptics npi-200 pupillometer).Field service technician was dispatched onsite to investigate this report and to attempt to better quantify/isolate the failure components.Service call # (b)(4), work order # (b)(4) was created for the onsite visit.The field service technician went onsite and determined that the artifact is being introduced by the older neuroptics pupillometer smart guard readers that the customer has.Six of the nine reader that the customer has are the older model.No capa was opened for this issue.Per (b)(4), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Udi / serial number not applicable.Further review of investigation details to be carried out.

• Brand Name: CNS DEVICE INTERFACE NEUROPTICS NPI-200 PUPILLOMETER
• Type of Device: CNS DEVICE INTERFACE NEUROPTICS NPI-200 PUPILLOMETER
• Manufacturer (Section D): NATUS NEUROLOGY INCOPORATED; 3150 pleasant view road; middleton, 53562 WI
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 3150 pleasant view road; middleton, 53562, WI
• MDR Report Key: 17911685
• MDR Text Key: 325377848
• Report Number: 3010611950-2023-00002
• Device Sequence Number: 1
• Product Code: GWL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAB-221
• Device Catalogue Number: CAB-221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1