MAUDE Adverse Event Report: BIO-MED BIO-MED; O2 AIR BLENDER

Model Number 2003

Device Problems Output above Specifications (1432); Defective Device (2588)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/21/2014

Event Type  Injury  

Event Description

The blender oxygen output was higher than the setting on the unit.These findings would not explain patient's change of condition.Setting of 21% - read at 74.5%, 60% setting read 85.5%, 90% setting read 98.5%) air pump output set at 30 psi - actual 31.8 psi.O2 blender removed from use.These findings would not explain patient's change of condition.Patient was placed on the ttav equipment, but was desaturating.Connections checked and no leak was detected, patient was receiving adequate flow.The patient continued to desaturate and was placed on wall oxygen at 5 liter with immediate improvement in saturation.The equipment removed from the room, marked defective and sequestered for evaluation of the o2 blender and circuit.

• Brand Name: BIO-MED
• Type of Device: O2 AIR BLENDER
• Manufacturer (Section D): BIO-MED; guilford CT 06437
• MDR Report Key: 3805813
• MDR Text Key: 4479458
• Report Number: MW5036024
• Device Sequence Number: 1
• Product Code: BZR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2003
• Other Device ID Number: 633723
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 100