PHILIPS HEALTHCARE RECEIVED A COMPLAINT STATING THAT A BILITX DEVICE LEFT A BURN ON LUMBAR SPINE AND SACRUM. THE PATIENT WAS REPORTEDLY ADMITTED INTO THE HOSPITAL WITH BURNS OVER 8% OF THE BODY. THE CUSTOMER STATED THAT THE PATIENT RECEIVED A MRI OF THE SPINE AND IV ANTIBIOTICS. THE CUSTOMER ALSO STATED THAT THE TREATMENT IS IN PROGRESS, FURTHER EVALUATION AND WORK UP IS PENDING. IT IS UNKNOWN AT THIS TIME IF THE DEVICE MALFUNCTIONED AND IF THIS MALFUNCTION COULD CAUSE OR CONTRIBUTE TO A DEATH/SERIOUS INJURY SHOULD IT RECUR. THE CUSTOMER STATED THE DEVICE IS NOT AVAILABLE FOR PHILIPS TO EVALUATE. BASED ON A COMPLETE REVIEW OF THE COMPLAINT ALLEGATION, PHILIPS HEALTHCARE HAS DETERMINED THAT THE REPORTED ISSUE REQUIRES FURTHER INVESTIGATION. ONCE ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP ADDITIONAL INFORMATION REPORT WILL BE FILED TO DETAIL THE FINDINGS AND THE NEED FOR ANY POSSIBLE FURTHER ACTION.
D
Patient 1
THE CUSTOMER REPORTED THAT THE BABY WAS TREATED WITH A BILITX BLANKET AND NOTICE A BURN ON LUMBAR SPINE AND SACRUM. THE BABY WAS ADMITTED INTO THE HOSPITAL. CUSTOMER STATED BABY HAS A BURN OF 8% OF THE BODY.
N
Patient 1
THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. PER A VOICEMAIL FROM THE CUSTOMER, HE AND THE DOCTOR HE SPOKE WITH FEEL THAT THIS WAS NOT A BURN OR THE FAULT OF THE DEVICE. THE PATIENT WAS GIVEN IV ANTIBIOTICS AND TRANSFERRED TO A DIFFERENT HOSPITAL WITH A PEDIATRIC VASCULAR ANOMALY TEAM. NO TREATMENT WAS GIVEN FOR THE RASH/BURN. A PEDIATRIC SURGEON ALSO SAW THE BABY AND FEELS THE BABY HAS A VASCULAR ABNORMALITY, POSSIBLE HEMANGIOMA. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND THE CUSTOMER STATED THEY FEEL THE DEVICE DID NOT MALFUNCTION. THE PARENTS OF THE PATIENT WERE USING THE DEVICE AT HOME AT THE TIME OF THE INCIDENT. IT IS UNKNOWN IF THE DEVICE WAS BEING USED CORRECTLY. THE DEVICE IS IN STORAGE AT THE CUSTOMER SITE PER RISK ASSESSMENT (B)(4): TEMPERATURE TESTING HAS VERIFIED THAT THE PHOTOTHERAPY PANEL MAINTAINS A SAFE TEMPERATURE DURING PHOTOTHERAPY AND THE SURFACE TEMPERATURE OF LED LIGHT ENGINE DURING OPERATION IS NOT HOT ENOUGH TO CAUSE A BURN. NO PRODUCT MALFUNCTION CAN BE DETERMINED. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED. IF THE PRODUCT IS RETURNED THIS COMPLAINT WILL BE OPENED TO INVESTIGATE.
D
Patient 1
THE CUSTOMER REPORTED THAT THE BABY WAS TREATED WITH A BILITX BLANKET AND NOTICE A BURN ON LUMBAR SPINE AND SACURM. THE BABY WAS ADMITTED INTO THE HOSPITAL. CUSTOMER STATED BABY HAS A BURN OF 8% OF THE BODY.THERE WAS A REPORT OF A SERIOUS INJURY. THE PATIENT WAS GIVEN IV ANTIBIOTICS AND TRANSFERRED TO A DIFFERENT HOSPITAL WITH A PEDIATRIC VASCULAR ANOMALY TEAM. NO TREATMENT (I.E. SALVE OR OINTMENT) WAS GIVEN FOR THE RASH/BURN. PER THE CUSTOMER, HE AND THE DOCTOR HE SPOKE WITH FEEL THAT THIS WAS NOT A BURN OR THE FAULT OF THE DEVICE. THE PRODUCT WAS IN USE WHEN THE REPORTED PROBLEM OCCURRED.