MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-15 for DAAVLIN 3 SERIES PC 861PH0048PC6 manufactured by Daavlin Distributing Co..
[19693147]
Biomed, (b)(6), called to verify they had followed proper procedure in calibrating their medical device. Correct procedure was not followed; they did not use a daavlin approved light meter and outputs received were not accurate, they also did not follow the dose correction procedure properly. We informed them that treating pts with the value they entered could result in over treatment. We were informed that at least one pt had already been treated, resulting in serious erythema requiring medical treatment, as calibration of the device had been 2 weeks prior. Daavlin cooperated with (b)(6) for recalibration and safety checks on (b)(4) 2012, with onsight visit. Follow up conversation with (b)(6) indicates (b)(6) was conducting a linked investigation, but refused to release pt info to daavlin due to pt privacy policy grounds.
Patient Sequence No: 1, Text Type: D, B5
[19787653]
Daavlin device was calibrated with non-daavlin approved meter. It is believed that the national biological meter is intended to calibrate their devices with the meter closer to the lamps (on the grid) while daavlin's meters are intended to calibrate devices by measuring uv flux at the point where the pt's skin will be. The low output recorded in this case by the national biological meter shows that this could be a serious safety concern if national biological meters are not meterologically accurate at commonly used calibration distances.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526255-2012-30373 |
| MDR Report Key | 2729306 |
| Report Source | 06 |
| Date Received | 2012-08-15 |
| Date of Report | 2012-08-15 |
| Date Mfgr Received | 2012-07-11 |
| Device Manufacturer Date | 2006-04-27 |
| Date Added to Maude | 2012-09-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. MICHELE THIEL |
| Manufacturer Street | 205 WEST BEMENT ST. PO BOX 626 |
| Manufacturer City | BRYAN OH 43506626 |
| Manufacturer Country | US |
| Manufacturer Postal | 43506626 |
| Manufacturer Phone | 4196366304 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAAVLIN |
| Generic Name | 3 SERIES PC PHOTOTHERAPY DEVICE |
| Product Code | FTC |
| Date Received | 2012-08-15 |
| Model Number | 3 SERIES PC |
| Catalog Number | 861PH0048PC6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAAVLIN DISTRIBUTING CO. |
| Manufacturer Address | BRYAN OH 43506 US 43506 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-15 |