NEWBORN BILI-BONNET 01B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-29 for NEWBORN BILI-BONNET 01B manufactured by Small Beginnings Inc..

Event Text Entries

[20161440] In newborn nursery a full-term female born via vaginal delivery with apgars nine and nine noted to be jaundiced was started on phototherapy. Small beginnings newborn bili-bonnet phototherapy mask was placed over the baby's eyes. At ten hours of age the baby was found not breathing and the mask was found positioned below the eyes. Code was called and baby was resuscitated and transferred to neonatal intensive care unit. Baby continued on life support. Evidence of worsening hypoxic-ischemic encephalopathy. After extensive discussion with family, life support removed. Autopsy pending.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 810312
• MDR Report Key: 810312
• Date Received: 2007-01-29
• Date of Report: 2007-01-29
• Date of Event: 2006-12-31
• Report Date: 2007-01-29
• Date Reported to FDA: 2007-01-29
• Date Added to Maude: 2007-01-31
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEWBORN BILI-BONNET
• Generic Name: PHOTOTHERAPY, MASK
• Product Code: FOK
• Date Received: 2007-01-29
• Model Number: 01B
• Catalog Number: 01B
• Lot Number: 07312006FB
• ID Number: *
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 797795
• Manufacturer: SMALL BEGINNINGS INC.
• Manufacturer Address: 17525 ALDER STREET, SUITE 28 HESPERIA CA 92345 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2007-01-29