MAUDE Adverse Event Report: BIRD PRODUCTS CORP. BIRD LOW FLOW OXYGEN BLENDER; LOW FLOW AIR-OXYGEN MICROBLENDER

Catalog Number ROBI1000

Device Problems No Audible Alarm (1019); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Incoming visual inspection found no anomalies.Technical evaluation found no visual anomalies.Device evaluation did not confirm the reported event as there was no problem found; therefore, a root cause cannot be determined.The device was recalibrated and tested to oem specifications.No additional investigation is required.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the blender was installed on the nicu transport incubator during testing the air unit was leaking from the back and the pressure imbalance alarm did not alert.There was no patient involvement.No additional information is available.

• Brand Name: BIRD LOW FLOW OXYGEN BLENDER
• Type of Device: LOW FLOW AIR-OXYGEN MICROBLENDER
• Manufacturer (Section D): BIRD PRODUCTS CORP.; 1100 bird center dr.; palm springs CA 92262
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 8941792
• MDR Text Key: 167651170
• Report Number: 3007409280-2019-00010
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROBI1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1