FDA Adverse Event
Malfunction
Summary report: N
INOMAX DSIR
MDR report key: 3203996
·
Received June 3, 2013
Report
- Report Number
- 3203996
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- April 20, 2013
- Report Date
- June 1, 2013
- Manufacturer
- INO THERAPEUTICS LLC/DBA IKARIA
- Product Code
- MRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
PATIENT WAS PLACED ON INOVENT. THE INOVENT WAS RUNNING WITHOUT ISSUES FOR ABOUT 35 MINUTES WHEN SYSTEM STARTED ALARMING DEVICE FAILURE. THE PATIENT'S VITAL SIGNS REMAINED STABLE AND UNCHANGED. THE SAMPLE LINE WAS REPLACED. THE INOVENT CONTINUED TO ALARM DEVICE FAILURE. THE NITRIC TANK WAS THEN SWITCHED TO A NEW UNOPENED TANK. THE INOVENT CONTINUED TO ALARM DEVICE FAILURE. A LOW CAL WAS DONE. THE INOVENT REMAINED ALARMING DEVICE FAILURE. THROUGHOUT THIS TIME THE PATIENT'S VITAL SIGNS REMAINED STABLE AND UNCHANGED. THE DECISION WAS MADE TO SWITCH OUT THE INOVENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RESPIRATORY VENTILATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243859 | INOMAX DSIR | APPARATUS, NITRIC OXIDE DELIVERY | MRN | INO THERAPEUTICS LLC/DBA IKARIA | INOMAX DSIR | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |