MAUDE Adverse Event Report: BREATH SYST 10MM HME MR 3M DISP; SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Model Number	6694145
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When attempting to connect the patient to the ventilator, it was found the tubing was malfunctioning and was coming apart.

• Brand Name: BREATH SYST 10MM HME MR 3M DISP
• Common Device Name: SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
• MDR Report Key: 9882678
• Report Number: 9882678
• Device Sequence Number: 11461770
• Product Code: BZO
• UDI-Device Identifier: 07325710002339
• UDI-Public: (01)07325710002339(10)181107(17)211107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/31/2020
• Report Date (Section F): 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6694145
• Device Lot Number: 181107
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 8 DA
• Date Report Sent to FDA: 01/31/2020