FDA Adverse Event
Summary report: N
INOMAX
MDR report key: 4251077
·
Received November 6, 2014
Report
- Report Number
- 4251077
- Date Received
- November 6, 2014
- Date of Event
- November 6, 2014
- Report Date
- November 6, 2014
- Manufacturer
- INO THERAPEUTICS LLC/DBA IKARIA
- Product Code
- MRN
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
OUR HOSPITAL CURRENTLY RENTS THE INOMAX FROM IKARIA. SINCE THE EQUIPMENT IS VENDOR OWNED, THEY DO ALL REPAIR/FAILURE INVESTIGATIONS AND MAINTENANCE. IT IS REQUIRED BY THE JOINT COMMISSION (TJC) THAT WE HAVE RECORDS FOR ALL EQUIPMENT, WHETHER OWNED, LEASED, ETC. FOR REVIEW AND TRENDING. THE COMPANY REFUSES TO SHARE ANY RECORDS OR CAUSES OF FAILURES WITH US TO MEET THE REQUIREMENTS. AT THIS TIME, THERE IS NOT ANOTHER VENDOR THAT HAS THIS TECHNOLOGY TO ALLOW US MOVE TO AWAY FROM IKARIA. WE CONTINUE TO REQUEST SERVICE REPORTS FROM THIS COMPANY, BUT THEY WILL NOT SHARE THEM WITH OUR CLINICAL ENGINEERING TEAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714119 | INOMAX | APPARATUS, NITRIC OXIDE DELIVERY | MRN | INO THERAPEUTICS LLC/DBA IKARIA | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |