MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORATED NICOLET VEEG SYSTEM; ELECTROCEPHLOGRAPH SYSTEM

Model Number 982A0506

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 10/24/2014

Event Type  Injury  

Manufacturer Narrative

This is a re-filing of report 3008289288-2014-00005 with a new report number.The report was edited on (b)(4) 2015 to revise the facility registration number from 3008289288 to 3010611950.The current facility registration number changed in may 2014 when natus neurology inc.Moved to its current location at (b)(4).Patient information: patient information was not provided, patient age and weight are therefore defaulted to "0".Device evaluated by manufacturer: device was not returned to manufacturer for evaluation.Registered internally as a complaint (reference (b)(4)) for further investigation by manufacturer.The internal investigation confirmed that the cart design had been successfully tip tested by the manufacturer and that the system in question may have caught on a threshold requiring that an unusual amount of force be used to try and move it which inadvertently tipped the cart.

Event Description

A hospital technician was moving a natus neurology nicone veeg monitoring system on a roll-able ergotron cart into/through an elevator.The cart tipped over injuring the technician.Cart labeling requires that the system must not extend up or out and that care must be used when pushing or pulling carts over depressed surfaces.There was no patient involvement at the time the incident occurred.

• Brand Name: NICOLET VEEG SYSTEM
• Type of Device: ELECTROCEPHLOGRAPH SYSTEM
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORATED; 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: 5068889
• MDR Text Key: 27329133
• Report Number: 3010611950-2015-00018
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 982A0506
• Device Catalogue Number: 982A0506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Patient Outcome(s): Other