MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE - CCDS SITE CCDS CRITICAL CARE DECONTAMINATION SYSTEM; DECONTAMINATION SYSTEM FOR RESPIRATORS

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

A battelle critical care decontamination system (ccds) worker, loading n95 respirators into the ccds decontamination chamber, reported having burning in their nose.The worker was wearing level iv personal protective equipment (ppe).The ccds bioquell unit was turned on for a couple of minutes.This resulted in vaporized hydrogen peroxide entering the chamber and the levels of vaporized hydrogen peroxide in the back of the decontamination chamber to reach 6.6 ppm.The ccds worker decon'ed and exited the chamber.The level iv ppe powered air-purifying respirator (papr) filters are independently tested to protect against 75 ppm h2o2 exposure.The worker went to urgent care and was released without treatment.This report is required under the terms of the battelle ccds eua.All information known or reasonably known to battelle has been included in this submission.

Event Description

A battelle critical care decontamination system (ccds) worker, loading n95 respirators into the ccds decontamination chamber, reported having burning in their nose when vaporized hydrogen peroxide entered the chamber.The worker was wearing level iv ppe with a powered air-purifying respirator (papr).The worker went to urgent care and was released without treatment.

• Brand Name: CCDS CRITICAL CARE DECONTAMINATION SYSTEM
• Type of Device: DECONTAMINATION SYSTEM FOR RESPIRATORS
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE - CCDS SITE; jefferson city MO
• Manufacturer (Section G): CCDS SITE; jefferson city MO
• Manufacturer Contact: carl smerdel ; 505 king ave; columbus, OH 43201 ; 6144247950
• MDR Report Key: 11351179
• MDR Text Key: 233250512
• Report Number: 1523658-2021-00072
• Device Sequence Number: 1
• Product Code: QKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other