MAUDE Adverse Event Report: NEB KIT W ADAPTER STERILE WATER 1000ML; HUMIDIFIER NEBULIZER KIT

Model Number	NEB KIT W ADAPTER STERILE WATER 1000ML
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Pma/ 510(k): enforcement discretion.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the neb kit w adapter sterile water 1000ml experienced failure to nebulize as a result patient's trach dried out and experienced thicker secretions.As an intervention, replaced vyaire system with f&k system.
Additional Manufacturer Narrative
Device evaluation: d9, g3, g6, h2, h3, h6 and h10.Result of investigation: samples received for evaluation.Vacuum test was performed and all samples failed the test.Therefore, reported defect was confirmed.Found broken o-ring upon removing the heatshell that caused the product to fail.

• Brand Name: NEB KIT W ADAPTER STERILE WATER 1000ML
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12428687
• Report Number: 8030673-2021-00194
• Device Sequence Number: 3391511
• Product Code: OGG
• UDI-Device Identifier: 10190752158450
• UDI-Public: (01)10190752158450(10)ZI-2101017(10)ZI-2012348
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NEB KIT W ADAPTER STERILE WATER 1000ML
• Device Catalogue Number: CK0010
• Device Lot Number: ZI-2012348, ZI-2101017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/06/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention