MAUDE Adverse Event Report: PRECISION MEDICAL INC. PRECISION MEDICAL INC; AIR-OXYGEN BLENDER

Model Number PM5300

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/18/2014

Event Type  Injury  

Event Description

Nicu patient was being ventilated on hfov.Blender was set to 100%.Patient o2 saturations decreased.Oxygen analyzer was reading 74% so it was exchanged with a new one that was calibrated.The replacement oxygen analyzer also was reading in the 70s.The hfov was replaced with a new oxygen blender.After replacement, the new ventilator, blender and analyzer were correlating.

• Brand Name: PRECISION MEDICAL INC
• Type of Device: AIR-OXYGEN BLENDER
• Manufacturer (Section D): PRECISION MEDICAL INC.; northampton 18067
• MDR Report Key: 4365059
• MDR Text Key: 18039033
• Report Number: MW5039810
• 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
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM5300
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 DA