FDA Adverse Event
Malfunction
Summary report: N
INOMAX DSIR
MDR report key: 3203984
·
Received June 3, 2013
Report
- Report Number
- 3203984
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- April 17, 2013
- Report Date
- May 30, 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
NITRIC OXIDE MONITOR FAILURE - WOULD NOT TURN ON CORRECTLY. THE DEVICE WOULD BOOT UP TO A DEVICE FAILURE ALARM EVERY TIME IT WAS POWERED ON. IKARIA TECH SUPPORT CONTACTED AND THE DEVICE HAS BEEN PICKED UP. NO LOGS ARE AVAILABLE AT THE USER END TO DOWNLOAD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PRE-OP NO DELIVERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243858 | INOMAX DSIR | APPARATUS, NITRIC OXIDE DELIVERY | MRN | INO THERAPEUTICS LLC/DBA IKARIA | INOMAX DSIR | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |