PRECISION MEDICAL CHROMEBODY FLOWMETER IMFA 1001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-31 for PRECISION MEDICAL CHROMEBODY FLOWMETER IMFA 1001 manufactured by Precision Medical, Inc..

Event Text Entries

[4526] One of the critical care nurses identified a potential problem while placing a patient on oxygen. Fortunately, there were no injuries involved. As she was about to place a patient on oxygen (via nasal cannula), she noticed that the ball on the flowmeter was descending slowly. She tried to readjust the flow to two liters but, again, to no avail. The ball remained on two liters momentarily, and then very slowly descended to zero. The nurse identified the situation to the assistant director of facility management. He in turn, contacted me. After close observation the flowmeter preformed exactly as the nurse described the ball very slowly descended to zero. To side track to the week prior, theree flowmeters were sent back to manufacture because of the inability to set the ball on one liter. The problem was that if you attempted to set the liter flow at one liter, the ball would instantaneously fall to zero. The problem that we are reproting now is entirely different. The ball descends very slowly until it reaches zero, which can in effect go unnoticed causing serious consequences. I relayed the information to quality control manager (manufacture). He said that there were problems with the needle valve seating, and this could be caused by continuously opening and closing of the needle valve. I also asked him if there were any other lot numbers of flowmeters that could potentially pose a problem. He identified two, both of which were of the same manufacturer. Device labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination. Results of evaluation: manufacturing. Conclusion: device failed just prior to use. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, use of all similar devices stopped permanently. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6363
• MDR Report Key: 6363
• Date Received: 1993-08-31
• Date of Report: 1993-08-04
• Date of Event: 1993-07-27
• Date Facility Aware: 1993-07-27
• Report Date: 1993-08-04
• Date Reported to FDA: 1993-08-04
• Date Reported to Mfgr: 1993-07-27
• Date Added to Maude: 1993-09-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PRECISION MEDICAL CHROMEBODY FLOWMETER
• Product Code: ETL
• Date Received: 1993-08-31
• Model Number: IMFA 1001
• Catalog Number: IMFA 1001
• Lot Number: 084
• ID Number: 0
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JAN-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6052
• Manufacturer: PRECISION MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-31