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 1992-03-26 for PSORALITE COM FLEX JOULEE 4.1 55000 N/A manufactured by Psoralite Corporation.

Event Text Entries

[16397540] The patient came to the determatology department for phototherapy treatment. Their 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 bot uva and uvb. The doctor was called ant 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 willtrack this incident as part of its quality assurance program, as will the safety committeedevice 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 Number470
MDR Report Key470
Date Received1992-03-26
Date of Report1992-02-21
Date of Event1991-11-18
Date Facility Aware1991-11-21
Report Date1992-02-21
Date Reported to FDA1992-02-21
Date Reported to Mfgr1992-01-13
Date Added to Maude1992-05-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePSORALITE COM FLEX JOULEE 4.1
Generic NamePUVA
Product CodeKGL
Date Received1992-03-26
Model Number55000
Catalog NumberN/A
Lot NumberN/A
ID NumberFMLH #13320
OperatorOTHER
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key464
ManufacturerPSORALITE CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-03-26

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