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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2020

Event Type  malfunction  

Event Description

A battelle critical care decontamination system (ccds) worker was loading n95 respirators into the ccds decontamination chamber when vaporized hydrogen peroxide entered the chamber.The worker was wearing level iv ppe with a powered air-purifying respirator (papr).There was no report of injury.The worker went to urgent care and was released without treatment.

Manufacturer Narrative

A battelle critical care decontamination system (ccds) worker was loading n95 respirators into the ccds decontamination chamber.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.There was no report of injury.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.

• 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
• MDR Report Key: 11351247
• MDR Text Key: 280444283
• Report Number: 1523658-2021-00073
• Device Sequence Number: 1
• Product Code: QKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1