MAUDE Adverse Event Report: PRECISION MEDICAL INC. PRECISION MEDICAL BLENDER; BREATHING GAS BLENDER

Model Number PM5200

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Cannula connected to a flow meter connected to a air oxygen blender.Blender is incapable of producing water, source of water could be the condensing of warm moist air, when passed thru cannula, heater circuit should be in place to warm air and keep air from condensing causing the moisture.

Event Description

Pt found on high flow nasal cannula equipment over flowing with water entering tubing attached to patient and rushing into patient nose.Immediately disconnected patient from machine.

• Brand Name: PRECISION MEDICAL BLENDER
• Type of Device: BREATHING GAS BLENDER
• Manufacturer (Section D): PRECISION MEDICAL INC.; 300 held drive; northampton PA 18067
• Manufacturer (Section G): PRECISION MEDICAL INC.; 300 held drive; northampton PA 18067
• Manufacturer Contact: jim parker ; 300 held drive; northampton, PA 18067 ; 6102626090
• MDR Report Key: 6224811
• MDR Text Key: 64353761
• Report Number: 2523148-2017-00001
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 00855887006009
• UDI-Public: 00855887006009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: PM5200
• Device Catalogue Number: PM5200
• Is the Reporter a Health Professional?: No
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2016
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/05/2017
• Date Device Manufactured: 02/10/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 MO