UV RADIOMETER
Received Sep 18, 2019 · Event occurred Apr 26, 2019
Report 9083132 · MDR key 9083132
Device
Generic name
Phototherapy Booth
Manufacturer
DaavlinProduct problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Calibration Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE DERMATOLOGY CLINIC HAS BEEN PERFORMING PHOTOTHERAPY FOR SEVERAL YEARS. THEY UTILIZE A DAAVLIN NARROWBAND UVB BOOTH. THE BOOTH IS CALIBRATED WITH A GIGAHERTZ-OPTIK CALIBRATOR. THE CALIBRATOR HAS BEEN IN USE SINCE THE INCEPTION OF THE PHOTOTHERAPY PROGRAM. RECENTLY, DAAVLIN, THE MAKER OF THE PHOTOTHERAPY BOOTH, NOTIFIED THE HOSPITAL THAT THE CALIBRATOR HAD BEEN DISPLAYING READINGS UNDER THE ACTUAL READING FOR TL01 & TL12 CALIBRATION. THE INITIAL DOSE OF PHOTOTHERAPY IS BASED UPON THE PROTOCOL USED BY DERMATOLOGISTS. THE SUBSEQUENT DOSES FOR THE THERAPY ARE BASED UPON PATIENT RESPONSE. THERE HAVE BEEN NO HARM EVENTS RELATED TO THE UNDER CALIBRATION OF THE PHOTOTHERAPY BOOTHS.