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

Model Number 0197

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/05/2016

Event Type  malfunction  

Event Description

Patient was on 4l/nc o2 and his sats were 61%.O2 was on.The regulatory was changed out and the patient's sats went up to 91%.

• Brand Name: OXYGEN FLOWMETER
• Type of Device: FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED
• Manufacturer (Section D): PRECISION MEDICAL, INC.; 300 held dr.; northampton PA 18067
• MDR Report Key: 6965120
• MDR Text Key: 89845847
• Report Number: 6965120
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR