DAAVLIN SPECTRA 305/350 PHOTOTHERAPY UNIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-04 for DAAVLIN SPECTRA 305/350 PHOTOTHERAPY UNIT manufactured by Daavlin Company.

Event Text Entries

[15607502] The physician entered a dose of 7 joules of uva and 1:30 minutes of uvb, placed a pt in the cabinet and told him to get out when the lamps went off. Evidently, the uva lamps shut off at the end of 7 joules as they were supposed. However, the control system for the uvb lamps failed to shut off. At 5:15 the doctor's nurse was closing the office when she noticed the pt was still in the cabinet with the uvb lamps on. The pt took the dr. Quite liteerally and remained for up to 43 minutes. The pt sustained a severe sunburn that required hospilization. Device not labeled for single use. Patient medical status prior to event: unknown. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: electrical problem. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: inserviced by manufacturer/distributor representative. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 38517-1994-09001
• MDR Report Key: 8389
• Date Received: 1994-08-04
• Date of Report: 1994-06-22
• Date of Event: 1993-01-26
• Report Date: 1994-06-22
• Date Reported to FDA: 1994-06-22
• Date Added to Maude: 1994-09-16
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DAAVLIN SPECTRA 305/350 PHOTOTHERAPY UNIT
• Product Code: KGL
• Date Received: 1994-08-04
• Model Number: 305/350
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8064
• Manufacturer: DAAVLIN COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-08-04