MAUDE Adverse Event Report: NATUS MEDICAL INC. NATUS BILIBAND EYE PROTECTOR; PAD, NEONATAL EYE

Device Problems Device Slipped (1584); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  Injury  

Event Description

Natus biliband eye protector ¿ potentially unsafe faulty product- potential infant suffocation risk.This event reported occurs all the time at (b)(6) mom and baby unit run by ms.(b)(6).My newborn daughter was receiving phototherapy as treatment for jaundice at (b)(6) mom and baby unit run by ms.(b)(6).The nurse on duty applied a new natus biliband eye protector on our daughter¿s eyes to shield her from the powerful lights used in the natus neoblue phototherapy treatment.Approximately an hour later, i discovered with horror that the natus biliband eye protector had slipped downwards and was covering both my daughter¿s nose and mouth.My daughter¿s nose and mouth were covered by the natus biliband eye protector and she was frantically shaking her hands in the bottom of the giraffe omnibed phototherapy unit which was heated to the mid-nineties.I reached for my cell phone to snap a photo, but instead put my phone down and quickly opened the giraffe omnibed phototherapy unit for the first time.I immediately lifted and pulled the natus biliband eye protector back into place, at which point i could again see her nose, and i witnessed her nostrils rapidly flare twice and then she went to sleep.I believe the natus biliband eye protector was asphyxiating our newborn daughter.I believe she was being suffocated by the natus biliband eye protector which had slipped downwards covering her nose and mouth, the entire time the natus biliband eye protector remained tightly wrapped around her face.The thick left foam-like eye-pad was tightly pressing against our daughter¿s nose and mouth.She was silent, she could not alert us by crying because her mouth was covered.Later other nurses applied new natus biliband eye protectors and we were able to catch them as they covered her nose.What we observed is that when the tightly wrapped natus biliband eye protector slips downward, it comes across the tip of the nose at which point the infant¿s nostrils are pinned shut making it near impossible for the newborn to breathe.Although i am curious as to whether the large inner foam eye-pads located on the inside of the natus biliband eye protector are porous and allow air flow, the force of a tightly wrapped natus biliband eye protector which has slid down the face and pins the nostrils shut, in my opinion, poses a serious risk of asphyxiation to the infant.The natus biliband eye protector came down around our baby¿s nostrils many times regardless of which nurse applied it (many new natus biliband eye protectors were used).Nurses at the (b)(6) mom and baby unit informed me that the natus biliband eye protector is found covering infants¿ nostrils and mouths all the time in the mornings.On their website, natus promotes their natus biliband eye protector as a solution the ¿stays in place¿ and is ¿safe and comfortable ¿.The ¿manual of neonatal care 7th by coherty¿ with regards to the natus biliband eye protector states, ¿care should be taken to ensure that eye patches do not occlude the nares, as asphyxia and apnea can result¿.I am sure the natus representative will cite all sorts of excuses in defense including: ¿improper sizing¿, ¿overstretched¿, ¿improper securing¿, ¿improper positioning¿, ¿improper use¿.The natus biliband eye protector is, in my opinion and that of other (b)(6) doctor and nurses, a faulty product.Speaking from personal experience, i believe the natus biliband eye protector is a dangerous product which can kill or seriously harm infants.I found my daughter¿s nose and mouth covered inside a plastic box heated to the mid-nineties.She was unable to cry out for help because the natus biliband eye protector was covering her mouth, and i believe she was not getting enough oxygen.Please examine the natus biliband eye protector and have it recalled if you too believe the natus biliband eye protector to be a dangerous, faulty, medical device.

• Brand Name: NATUS BILIBAND EYE PROTECTOR
• Type of Device: PAD, NEONATAL EYE
• Manufacturer (Section D): NATUS MEDICAL INC.
• MDR Report Key: 8289652
• MDR Text Key: 134898978
• Report Number: MW5083472
• Device Sequence Number: 1
• Product Code: FOK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention