MAUDE Adverse Event Report: DAAVLIN DISTRIBUTING COMPANY DAAVLIN; SPECTRA, 311/350

Model Number SPECTRA, 311/350

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Radiation Burn (1755); Burn(s) (1757); Injury (2348)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

A physician informed daavlin that a patient has initiated malpractice litigation against said physician for alleged burns following an accidental overdose.Per physician, and civil court filings, the patient alleges that symptoms of erythema have lasted longer than 7 days though the treating physician deny the severity of the symptoms.This incident took place during the patients first treatment.Internal office protocol indicates that 150mj of narrow band uvb treatment was prescribed for the first treatment, however, the operator delivered 1,500mj narrow band uvb treatment.The device associated with this report has been regularly serviced and calibrated, prior to and after the event in question, by daavlin authorized service technicians and has been determined to be in good working condition.The treating physicians agree and are all under the opinion that the overdose was strictly due to operator use error.In so much as the device contributed to the error, it was only by means of operator misuse/error.

Manufacturer Narrative

A 1,500mj dose of narrow band uvb light would typically be reached within 3-4 weeks of narrow band uvb treatment of a fitzpatrick skin type ii patient.It is a dose that might be delivered to a treatment naive skin type ii patient as a part of photopatch testing, or directly to a psoriatic lesion with a targeted light source, but it would be expected to cause erythema in non-lesional skin.The device associated with this report has been regularly serviced and calibrated, prior to and after the event in question, by daavlin authorized service technicians and has been determined to be in good working condition.The conclusion is that this event is attributable to human factors issues where use error, the interaction between the device and user, directly caused the event.The treating physicians agree and are all of the opinion that the overdose was strictly due to operator use error.In so much as the device contributed to the event, it was only by means of operator use error/ misuse.There was no direct failure attributable to the device itself and it has been determined that the device operated within specification.

• Brand Name: DAAVLIN
• Type of Device: SPECTRA, 311/350
• Manufacturer (Section D): DAAVLIN DISTRIBUTING COMPANY; bryan OH 43506
• Manufacturer Contact: timothy lehtonen ; 205 west bement street; p.o. box 626; bryan, OH 43506 ; 4196366304
• MDR Report Key: 4471077
• MDR Text Key: 5189119
• Report Number: 1526255-2015-00001
• Device Sequence Number: 1
• Product Code: FTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K828654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPECTRA, 311/350
• Device Catalogue Number: 821PH2424V6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization