MAUDE Adverse Event Report: STERILIZ LLC R-D RAPID DISINFECTOR; DISINFECTOR, MEDICAL DEVICES

Model Number UV-C

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Computer Operating System Problem (2898); Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2016

Event Type  malfunction  

Event Description

(words are from the nurse operating the machine).I spoke with a rep from the steriliz company regarding our unit #221, i rebooted the unit and spoke with a gentleman by the name of (b)(4).The unit responded, and i was able to log in and out several times, and it appeared that the unit was ready to start a 'job'.I spoke with (b)(4) again and he said he remoted in to the unit and it was working and then just lost connection.He asked me to try again to reboot and to attempt a job.I went to room 7 set the machine up and the tablet let me program the job, and start the job.Three of the 4 sensors were showing dose received and remaining time on the job (sensor 4 was 'calculating' throughout this time).As i was watching the time count down, after about 3 minutes, the countdown stopped on all 3 sensors (4 continues to show 'calculating'), i attempted to pause the unit, it did not respond, i opened the door so the door sensor would stop the unit, it did not stop the unit.I went to get (b)(4) phone number and i called him from just outside room 7.He attempted to remote in and stated the computer of the unit froze and the only way to turn it off was to don ppe and go in and unplug.This was done.I mentioned to (b)(4) that we were assured that this could not happen.(b)(4) said the computer of the unit will probably have to be replaced.According to our sales rep, the software version is 4.15.From what i'm told, the machine has malfunctioned 2-3 times in the past month.I understand at least twice the machine was reported to steriliz.The manufacturer is replacing our unit and picking up the reported unit for evaluation.Manufacturer response for uv disinfector, steriliz (per site reporter): tech support believes we need a new computer.

• Brand Name: R-D RAPID DISINFECTOR
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): STERILIZ LLC; 95 allens creek rd; bldg 2 suite 205; rochester NY 14618
• MDR Report Key: 5669503
• MDR Text Key: 45603839
• Report Number: 5669503
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: UV-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1