MAUDE Adverse Event Report: PRECISION MEDICAL INC PRECISION MEDICAL; DIAL FLOWMETER, OXYGEN

Model Number BM7MFA1001

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 02/06/2017

Event Type  malfunction  

Event Description

The dial flowmeters in pacu without float balls are a patient safety issue.If these are set between détentes there is no oxygen flow and no indication that there is no oxygen flow.Anesthesiologist noticed excessive expiratory humidity in his patient's mask and he determined that the flowmeter was sluggish and stuck between settings causing zero o2 flow.Thankfully, the patient maintained spo2 99%.Recommendation was to remove all non float ball flowmeters from service due to faulty design and replace them with flowmeters that use float balls.The dial flowmeters are being discarded.Incidentally, the dial flowmeters do have an indication written on the device that states, "no flow between settings." this is the manufacturer's warning to users of the issue identified by the anesthesiologist.

• Brand Name: PRECISION MEDICAL
• Type of Device: DIAL FLOWMETER, OXYGEN
• Manufacturer (Section D): PRECISION MEDICAL INC; 300 held dr.; northampton PA 18067
• MDR Report Key: 6590229
• MDR Text Key: 75940547
• Report Number: 6590229
• 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: Other
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BM7MFA1001
• Device Catalogue Number: 7MFA1001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2017
• 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
• Treatment: NO