MAUDE Adverse Event Report: VYAIRE MEDICAL HUMIDIFIER KIT 500ML 12/CS; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number HUMIDIFIER KIT 500ML 12/CS

Device Problem Fitting Problem (2183)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the humidifier kit 500ml 12/cs adapter does not fit properly into the flowmeter.Due to this, a leakage occurred which caused a low oxygen saturation.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: HUMIDIFIER KIT 500ML 12/CS
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): LABORATORIOS PISA ; s.a. de c.v. carretera san isi; dro mazatepec # 7000 tlajomulc; jalisco 45645 ; MX 45645
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16573827
• MDR Text Key: 312198032
• Report Number: 3013421741-2023-00027
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10885403070983
• UDI-Public: (01)10885403070983(10)TL2208057
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K853146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2023

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
• Device Operator: Health Professional
• Device Model Number: HUMIDIFIER KIT 500ML 12/CS
• Device Catalogue Number: 2620
• Device Lot Number: TL2208057
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1