MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS WALLABY II; UNIT, NEONATAL PHOTOTHERAPY

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Burn(s) (1757); Full thickness (Third Degree) Burn (2696)

Event Date 04/15/2014

Event Type  Injury  

Event Description

Patient required immediate iv access post birth due to complicated vaginal delivery and was lethargic upon immediate presentation.This baby required blood tests and iv antibiotics and required venous and arterial access.The wallaby ii phototherapy machine was being used as a transilluminator to find venous and arterial access.Attempts were made on both ankles and right wrist.The 0.5cm circular blisters were noted bilaterally on the lateral aspects of both ankles and a 0.5cm reddened circular area was noted on the right wrist.

• Brand Name: WALLABY II
• Type of Device: UNIT, NEONATAL PHOTOTHERAPY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 5675386
• MDR Text Key: 241271928
• Report Number: 5675386
• Device Sequence Number: 1
• Product Code: LBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2016
• Device Age: 20 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other