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	Defective Device (2588)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Samples of the device was returned for evaluation.The defect reported by the customer was not confirmed and functional tests were carried out without any issues found.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Pma/ 510(k) - enforcement discretion.
Event or Problem Description
The customer reported that the neb kit w adapter sterile water 1000ml quits nebulizing and they have had kids tracheostomy plug off and they then decompensate.Patient airway was obstructed by secretions.As an intervention, the patient just had to be aggressively suctioned to clear out airway.

• Brand Name: NEB KIT W ADAPTER STERILE WATER 1000ML
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 11289315
• Report Number: 8030673-2021-00146
• Device Sequence Number: 4228269
• Product Code: OGG
• UDI-Device Identifier: 10885403221484
• UDI-Public: (01)10885403221484(10)0004150098
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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: 0004150098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/05/2021
• 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