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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAAVLIN UV RADIOMETER; PHOTOTHERAPY BOOTH
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DAAVLIN UV RADIOMETER; PHOTOTHERAPY BOOTH Back to Search Results
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2019
Event Type  malfunction  
Event Description
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.
 
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Brand Name
UV RADIOMETER
Type of Device
PHOTOTHERAPY BOOTH
Manufacturer (Section D)
DAAVLIN
205 west bement str
bryan OH 43506
MDR Report Key9083132
MDR Text Key159041024
Report Number9083132
Device Sequence Number1
Product Code FTC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/29/2019,04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/29/2019
Device Age10 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/17/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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