FDA Adverse Event
Malfunction
Summary report: N
INOMAX DS (DELIVERY SYSTEM)
MDR report key: 1881344
·
Received October 7, 2010
Report
- Report Number
- 3004531588-2010-00086
- Event Type
- Malfunction
- Date Received
- October 7, 2010
- Date of Event
- September 10, 2010
- Report Date
- October 7, 2010
- Manufacturer
- INO THERAPEUTICS, LLC/IKARIA
- Product Code
- MRN
- PMA / PMN Number
- K061901
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE INVESTIGATION OF THE DEVICE IS COMPLETE AND IS AS FOLLOWS: THE DEVICE WAS BEING USED IN AN OFF-LABEL, LONG-TERM APPLICATION WHICH WAS NOT ANTICIPATED. A REVIEW OF THE SERVICE LOGS YIELDED THE ALARM. "SERVICE REQUIRED" RESULTING IN A SYSTEM SHUTDOWN. A SOFTWARE ANOMALY WAS FOUND TO BE THE ROOT CAUSE OF THE INCIDENT. THE SOFTWARE HAS BEEN MODIFIED TO ELIMINATE THE ANOMALY.
Description of Event or Problem · 1
ON (B)(6), 2010, A RESPIRATORY THERAPIST REPORTED THAT THE INOMAX DS, # (B)(4) WENT INTO DELIVERY FAILURE DURING BOOT UP. THE DEVICE WAS NOT ON A PT AND NO ADVERSE EVENT WAS REPORTED BY THE RESPIRATORY THERAPIST. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND RETURNED TO THE COMPANY FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INOMAX DS (DELIVERY SYSTEM) | APPARATUS, NITRIC OXIDE DELIVERY | MRN | INO THERAPEUTICS, LLC/IKARIA | 10003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |