MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORTAED NATUS DISPOSABLE 4-DISK ELECTRODES

Model Number 019-409000

Device Problem Use of Device Problem (1670)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

Registered internally as a complaint ((b)(4)) for further investigation by natus.A separate mdr (3010611950-2016-00005) is being filed for a second, similar incident also reported under complaint (b)(4).Natus quality assurance was notified of this incident on june 2, 2016.Additional information requested by natus on june 9, 2016, collected and reported to natus by the customer on (b)(6) 2016 stated that the associated incident actually occurred on (b)(6) 2016.Eeg testing was described as "continuous eeg monitoring" that lasted 48 hours.The customer further described that the patient "developed a pressure injury to the forehead".The patient was described as a female, (b)(6).The customer reported the patient was subsequently treated with topical ointments for the injuries further explaining that the patient was a premature infant and "the device used was not a pediatric version".The electrodes used are identified in natus sales literature as "ideal for psg, ncs, sep, aep, emg, eng and iom studies".The customer also communicated they chose the electrodes for eeg monitoring because of the cushioned gel pad.The customer has since discontinued use of the indicated product for eeg monitoring of such patients.Since several months had subsequently elapsed, the patients weight was estimated to be one (1) kilogram in this report based on the patients reported age and condition (premature) when the incident occurred.In addition to the patient information, the customer also stated that no other natus devices were in use at the time of the incident.The customer had since disposed of the actual device used and could not provide lot traceability.Manufacturing records could therefore not be reviewed nor could the actual device in question be evaluated.

Event Description

Customer reported an infant received "pressure ulcers/pressure injuries" from the sticky electrodes during eeg testing.The infant was subsequently treated with topical ointments.

• Brand Name: NATUS DISPOSABLE 4-DISK ELECTRODES
• Type of Device: ELECTRODES
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORTAED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer Contact: randall moog ; 3150 pleasant view road; middleton, WI 53562 ; 6088298802
• MDR Report Key: 5750914
• MDR Text Key: 48214557
• Report Number: 3010611950-2016-00004
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K850108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 019-409000
• Device Catalogue Number: 019-409000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 DA
• Patient Weight: 1