MAUDE Adverse Event Report: BIRD PRODUCTS CORP. BIRD LOW FLOW AIR OXYGEN BLENDER; BMD AIR/OXYGEN BLENDER

Model Number FOBI1000

Device Problems Leak/Splash (1354); Material Integrity Problem (2978); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found light scratches on the case.Technical visual inspection found no anomalies.Device evaluation found that the air inlet threads were broken.The device was calibrated.The alarm calibration, inlet check valve leak test, outlet flow test, and final visual inspection were all tested and passed.The root cause for the confirmed reported event was determined to the alarm fastener.Based on device condition, it has been determined that the device has been dropped and tampered with.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device leaked while on.It is unknown if there was patient involvement.There was no patient harm.No additional information is available.

• Brand Name: BIRD LOW FLOW AIR OXYGEN BLENDER
• Type of Device: BMD AIR/OXYGEN BLENDER
• 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
• MDR Report Key: 9311766
• MDR Text Key: 167621141
• Report Number: 3007409280-2019-00093
• 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: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FOBI1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• 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