MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE; RESPIRATOR, DECONTAMINATED

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device not returned.Ccds staff has been in contact with hcp as well as sent guidance to sites to take care when handling masks during loading, unloading and packaging.Ccds staff explained that unpacking, loading and unloading of the mask into and out of the chamber then repacking into the bags can have an effect on the fit quality.

Event Description

User reported straps too loose to seal correctly.The masks associated with this event were decontaminated with the battelle ccds "closed system" process.

• Brand Name: NA
• Type of Device: RESPIRATOR, DECONTAMINATED
• 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: 10801490
• MDR Text Key: 215077513
• Report Number: 1523658-2020-00158
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1