MAUDE Adverse Event Report: RA MEDICAL SYSTEMS, INC. PHAROS EXCIMER LASER SYSTEM; EXCIMER PHOTOTHERAPY LASER

Model Number	EX-308
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	Erythema (1840)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A service technician inspected the device and found that below a setting of 100 mj, the device continued to dose as long as the finger fire button was pressed.This was confirmed by an engineering evaluation at the manufacturing facility.
Event or Problem Description
It was reported that a device malfunctioned on (b)(6) 2019.This was followed by a report on (b)(6) 2019 of a patient experiencing erythema after treatment with the ex-308.

• Brand Name: PHAROS EXCIMER LASER SYSTEM
• Common Device Name: EXCIMER PHOTOTHERAPY LASER
• Manufacturer (Section D): RA MEDICAL SYSTEMS, INC.; 2070 las palmas drive; carlsbad CA 92011
• MDR Report Key: 8916413
• Report Number: 2032864-2019-00005
• Device Sequence Number: 18892821
• Product Code: GEX
• UDI-Device Identifier: 00842362100017
• UDI-Public: (01)00842362100017(11)20190628
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 062963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EX-308
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1