PSORALITE COM FLEX JOULEE 4.1 55000 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-30 for PSORALITE COM FLEX JOULEE 4.1 55000 N/A manufactured by Psoralite Corporation.

Event Text Entries

[19550640] Phototherapy terminology:uva-ultraviolet a, a deep penetrating uv treatmentuvb-ultraviolet b, a skin surfacr uv treatmentpuva-psoralen ultraviolet a, the patient is medicated with psoralen and then treated with uvathe patient came to the dermatology department for phototherapy treatment. His chart was reviewed, the machine was programmed for uvb and the treatment was initiated. An error was discovered and the unit was stopped after five seconds of treatment. The machine was then turned off with the key and was reprogrammed for uva. It was discovered at the completion of the uva treatment that the uvb programming did not clear, so the patient received both uva and uvb. The doctor was called and the patient was treated for diffuse redness related to uvb exposure. Biomedical engineering indicated that the equipment was in working order, so the error was determined to be of a procedural nature. The manufacturer was contacted and suggested installing a new panel which would include safety features to prevent a repeat of this type of incident. The panel was installed and biomedical engineering will track this incident as part of its quality assurance program, as will the safety committee. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-91. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed. Results of evaluation: design, failure to follow instructions, invalid data. Conclusion: software/firmware contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, device temporarily removed from service, use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3070
• MDR Report Key: 3070
• Date Received: 1992-07-30
• Date of Report: 1992-02-21
• Date of Event: 1991-11-18
• Date Facility Aware: 1991-11-21
• Report Date: 1992-02-21
• Date Reported to Mfgr: 1992-01-13
• Date Added to Maude: 1993-04-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• 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: PSORALITE COM FLEX JOULEE 4.1
• Generic Name: PUVA UNIT
• Product Code: FTC
• Date Received: 1992-07-30
• Model Number: 55000
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: FMLH # 13320
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2871
• Manufacturer: PSORALITE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-30