MAUDE Adverse Event Report: NULL

Lot Number 210701

Device Problems Break (1069); Material Separation (1562)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: one hme filter was returned.As a result of observing the hmef (humidification attachment), it was confirmed that the hme filter housing is detached.The reported event was confirmed.It was determined that the event was caused by the manufacturing of the supplier.A sample was sent to the manufacturer to investigate the event.Review of manufacturing records, found no discrepancies or anomalies.

Event Description

It was reported that during the pre-use check, the hme (humidification attachment) filter was found broken.No patient injury was reported.

• Manufacturer (Section G): NULL
• MDR Report Key: 13197367
• MDR Text Key: 285680348
• Report Number: 3012307300-2022-00332
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 210701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1