MAUDE Adverse Event Report: VYAIRE MEDICAL INC. ULTRA MICROBLENDER SERIES; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number BLENDER

Device Problem Mechanical Problem (1384)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

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

The customer reported oxygen setting was not valid and did not set to pointed value during use on a patient on the ultra microblender series.The customer reported end user changed the blender with a back up device, and it was indicated that there poor saturation and delay in treatment.

Manufacturer Narrative

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

The customer reported oxygen setting was not valid and did not set to pointed value during use on a patient on the ultra microblender series.The customer reported end user changed the blender with a back up device, and it was indicated that there poor saturation and delay in treatment.

Manufacturer Narrative

Results of investigation: vyaire medical received the device for repair and evaluation.Root cause is undetermined.Vyaire engineer performed overhaul and calibration.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: ULTRA MICROBLENDER SERIES
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13578957
• MDR Text Key: 286084680
• Report Number: 2021710-2022-15476
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 10846446001952
• UDI-Public: (01)10846446001952(11)20190809
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K973646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

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
• Device Operator: Health Professional
• Device Model Number: BLENDER
• Device Catalogue Number: 10016A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention