MAUDE Adverse Event Report: PRECISION MEDICAL BLENDER, HIGH FLOW 2-120LPM; AIR OXYGEN BLENDER

Model Number PM5200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Abnormal Blood Gases (1034)

Event Date 05/08/2017

Event Type  Injury  

Event Description

Infant extubated and placed on cpap with room air(blender dialed to 21% oxygen) at 11am, at 4pm an abg was collected and the result noted a po2 of 429.Blender removed and checked and it was putting out 98% oxygen.Danger of baby developing rop.Dose or amount: 21%, frequency: continuous, route: ophthalmic.Dates of use: 5 hours.Diagnosis or reason for use: respiratory distress.Event abated after use stopped or dose reduced: yes.

• Brand Name: BLENDER, HIGH FLOW 2-120LPM
• Type of Device: AIR OXYGEN BLENDER
• Manufacturer (Section D): PRECISION MEDICAL; northhampton PA 18067
• MDR Report Key: 6604477
• MDR Text Key: 76507840
• Report Number: MW5070107
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: PM5200
• Device Lot Number: SNBH003477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 1