MAUDE Adverse Event Report: PRECISION MEDICAL, INC. OXYGEN HIGH PRESSURE HOSE; TUBING, PRESSURE AND ACCESSORIES

Model Number 81-3311-06

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 02/26/2020

Event Type  malfunction  

Event Description

New oxygen high pressure hose was found to be not patent upon first use.Hose was attached to an air / o2 blender.Blender was placed in use in our nicu.

• Brand Name: OXYGEN HIGH PRESSURE HOSE
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): PRECISION MEDICAL, INC. ; 300 held dr; northampton PA 18067
• MDR Report Key: 9785945
• MDR Text Key: 182328111
• Report Number: MW5093504
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-3311-06
• Device Lot Number: 1913813-0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1