MAUDE Adverse Event Report: PRECISION MEDICAL, INC. O2 FLOW METER; FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED

Model Number 0197

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/29/2019

Event Type  malfunction  

Event Description

While bagging a pt, the rt came in and stated that earlier she had trouble with the flow meter that the bag was on during an epi.I quickly changed it to the other 15 liter flow meter in the room and resumed bagging.

• Brand Name: O2 FLOW METER
• Type of Device: FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED
• Manufacturer (Section D): PRECISION MEDICAL, INC.
• MDR Report Key: 8604954
• MDR Text Key: 145031497
• Report Number: MW5086581
• Device Sequence Number: 1
• Product Code: CAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0197
• Device Lot Number: 300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 17 YR