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

Device Problems Stretched (1601); Dent in Material (2526); Material Too Soft/Flexible (4007)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned.Ccds staff and hcp are in discussion providing additional information concerning the decontamination process as well as faqs answering customer questions concerning mask fit.

Event Description

User reported lower elastic band is lose, the mask completely lost its shape, it had no structure to it, it sunk in the middle.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: 10801516
• MDR Text Key: 215066528
• Report Number: 1523658-2020-00191
• 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: 09/09/2020
• 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