GIRAFFE SPOT PT(LED)

Description of Event or Problem

GE HEALTHCARE BECAME AWARE OF A LAWSUIT FILED AGAINST A HOSPITAL AND INDIVIDUAL HEALTH CARE PRACTITIONERS REGARDING THEIR CARE OF A PREMATURELY BORN INFANT USING A GIRAFFE SPOT PT(LED) DEVICE. THE PATIENT EXPERIENCED A REACTION OR PHOTOSENSITIVITY. THE ALLEGATIONS AGAINST THE HOSPITAL AND HCPS STATE THAT PHOTOSENSITIVITY WAS CAUSED DUE TO A COMBINATION OF DYE STUDY PRIOR TO LABOR TO DETERMINE IF THERE WERE AMNIOTIC FLUID LEAKS AND PHOTOTHERAPY PRESCRIBED AFTER BIRTH TO THE PATIENT. THE PATIENT IS REPORTED TO HAVE SUFFERED PARTIAL THICKNESS BURNS, ORIGINALLY CLASSED AS FIRST DEGREE AND SUBSEQUENTLY DETERMINED TO BE SECOND DEGREE, THAT REQUIRED MEDICAL TREATMENT. THE RECORD DOES NOT ALLEGE THAT THE GIRAFFE SPOT PT(LED) DEVICE MALFUNCTIONED. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

Additional Manufacturer Narrative

GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK G2 REPORT SOURCE OTHER: (B)(6). LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

Additional Manufacturer Narrative

GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SPECIFIC GIRAFFE BLUE SPOT PT USED DURING PHOTOTHERAPY TREATMENTS WAS NOT IDENTIFIED OR ASSESSED. THE GIRAFFE BLUE SPOT PT HAS LITTLE WAVELENGTH IN EITHER THE IR (HEAT GENERATING) WAVELENGTHS OR THE UV (SUN BURNING) RANGES AND THEREFORE WOULD NOT BE EXPECTED TO RESULT IN A SKIN BURN.