MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM; DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Viral Infection (2248); Discomfort (2330); Nasal Obstruction (2466); Ageusia (4423); Cough (4457)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

A battelle critical care decontamination system ccdstm site worker had a positive diagnostic test result for sars-cov-2.The worker reported symptoms of cough, runny nose, nasal congestion, loss od sense of smell or taste, headache, body aches, fatigue.The battelle ccds site worker wore personal protective equipment (ppe) level 4 fully encapsulated protective suit with positive pressure and self-contained breathing apparatus while handling contaminated n95 respirators.Therefore, the ccds site worker's infection is not being attributed to the battelle critical care decontamination system ccds.The ccds is used in the decontamination of compatible n95 respirators to prevent exposure to pathogenic biological airborne particulates.Because the battelle ccds site worker is required, pursuant to battelle's standard operating procedures, to wear ppe level 4 fully encapsuled protective suit with positive pressure and self-contained breathing apparatus while handling contaminated n95 respirators, the site worker was not wearing a n95 respirator that had been reprocessed under the fda's emergency use authorization (eua) approved march 29, 2020, and revised and reissued on june 6, 2020.Battelle is submitting this report because the terms of the ccds eua as interpreted by fda require reporting of infections and potential infection of battelle personnel involved in the use of battelle decontamination system.Battelle is not aware of information to suggest the ccds or a n95 respirator handled during the decontamination process may have caused or contributed to the ccds site worker's infection.

Event Description

A battelle critical care decontamination system ccds site worker had a positive diagnostic test result for sars-cov-2.The worker reported symptoms of cough, runny nose, nasal congestion, loss od sense of smell or taste, headache, body aches, fatigue.The battelle ccds site worker wore personal protective equipment (ppe) level 4 fully encapsulated protective suit with positive pressure and self-contained breathing apparatus while handling contaminated n95 respirators.Therefore, the ccds site worker's infection is not being attributed to the battelle critical care decontamination system ccds.

• Brand Name: BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM
• Type of Device: DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE; 505 king ave; columbus OH 43201
• Manufacturer Contact: carl smerdel ; 505 king ave; columbus, OH 43201 ; 6144247950
• MDR Report Key: 11181483
• MDR Text Key: 231581634
• Report Number: 1523658-2021-00035
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/10/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other