PULMONOX II *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-12 for PULMONOX II * manufactured by Pulmonox Medical Corp..

Event Text Entries

[53381] Pt was connected to an oscillator ventilator and receiving nitric oxide (under clinical investigation). Noted that the actual reading of nitric oxide was measured at 40 ppm. Calculated level at a steady flow rate was 15 ppm. The clinical specialist, a rrt for the mfg was notified the same or next day of occurrence and was already aware that this problem could exist and stated that several people had seen this happen and suggested telephone call. Mention was made by her of an addenum to the operator's manual, however, this hosp had never received the update. Principal investigator for this study was to be notified. The manual addenum was faxed to the nicu and the recommended circuit was used but didn't alleviate the problem. Later it was discovered that the device hadn't been tested at low nitric settings and not on the oscillator ventilator. The co reps arrived at the hosp days later and plan to try to reproduce the event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 83208
• MDR Report Key: 83208
• Date Received: 1997-02-12
• Date of Report: 1996-12-10
• Date of Event: 1996-11-18
• Date Facility Aware: 1996-11-18
• Report Date: 1996-12-10
• Date Reported to Mfgr: 1996-12-10
• Date Added to Maude: 1997-04-15
• 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: 3
• Initial Report to FDA: 3
• 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: PULMONOX II
• Generic Name: NITRIC OXIDE AND NITROGEN DIOXIDE ANALYZER
• Product Code: MRP
• Date Received: 1997-02-12
• Model Number: PULMONOX II
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 82555
• Manufacturer: PULMONOX MEDICAL CORP.
• Manufacturer Address: 5111-52 AVE. TOFIELD ALBERTA CA TOB4JO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-02-12