MAUDE Adverse Event Report: NATUS MEDICAL INC. NATUS BILIBAND EYE PROTECTOR

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Natus technical service requested fda contact for more information to investigate the incident further, and fda was unable to release any further information that pertains to the report in question.If additional information becomes available natus will file a supplemental report.

Event Description

Natus medical received medwatch report number mw5083472 from the fda on 13 feb 2019.The report was submitted by a patient's parent regarding an alleged event involving the natus biliband eye protector.The alleged event occurred on (b)(6) 2018, when a newborn baby was receiving treatment for jaundice and wearing a biliband.An hour after a biliband was applied to the patient the mother of the patient stated she observed that the biliband had slid down beneath the eyes and was covering the baby's nose and mouth.The mother alleged that the foam-like eye-pad material appeared to be tightly pressed against the baby's nose and mouth and she believed that the eye protector was causing asphyxiation.She quickly opened the incubator and positioned the biliband eye protector back on the eyes and witnessed the baby's nostrils rapidly flare twice before the child went to sleep.Natus technical service requested more information from the fda however, the fda was unable to release any further information.

• Brand Name: NATUS BILIBAND EYE PROTECTOR
• Type of Device: BILIBAND
• Manufacturer (Section D): NATUS MEDICAL INC.; 5900 first ave south; seattle WA 98108
• Manufacturer (Section G): NATUS MEDICAL INC.; 5900 first ave south; seattle WA 98108
• Manufacturer Contact: james fitzgerald ; 5900 first ave south; seattle, WA 98108 ; 2062685173
• MDR Report Key: 8423580
• MDR Text Key: 139110322
• Report Number: 3018859-2019-00002
• Device Sequence Number: 1
• Product Code: FOK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other