MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-03 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[15998542]
Touch screen on the inomax dsir blank and not responding [device malfunction]. Case description: this initial non-serious device case report was received on (b)(6) 2014 from a respiratory therapist (rt) in the united states who called to report a "faulty display screen" on the inomax dsir ds20090537. The device was not in use at the time of the device issue. Ikaria investigation results were received on (b)(4) 2014. Relevant medical history/co-morbidities: no patient. Concomitant medications: not applicable. According to the rt, on (b)(6) 2014 "upon start up, the main screen of the inomax dsir ds 20090537 appeared for a few seconds then burned blank/black. " the rt stated there was "slight backlight to the screen making it almost appear pink in color". The rt cycled the ac power to standby then on however the touch screen on the inomax dsir was not responding. The device was not in use on a patient at the time of the device issue. The inomax dsir ds20090537 was returned to ikaria for inspection.
Patient Sequence No: 1, Text Type: D, B5
[16211843]
This initial non-serious device case report was received on (b)(6) 2014 from a respiratory therapist (rt) in the united states who called to report a "faulty display screen" on the inomax dsir ds20090537. The device was not in use at the time of the device issue. (complaint-(b)(4)). Investigation results completed on (b)(4) 2014. Case comment: (b)(4) 2014: this device was not in use at the time of device malfunction and did not result in an adverse event; however it is being reported because a similar malfunction occurred in the past that resulted in a serious adverse event (see mdr#3004531588-2013-00023). Evaluation summary: the inomax dsir ds20090537 was returned to ikaria's regional service center (rsc) for service evaluation. The rsc investigation confirmed and experienced the reported complaint of display going blank. The rsc replaced the display, shroud, and backlight inverter to correct the problem. The root cause for this incident is display - backlight failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00010 |
| MDR Report Key | 3880036 |
| Report Source | 05 |
| Date Received | 2014-04-03 |
| Date of Report | 2014-03-25 |
| Date Mfgr Received | 2014-03-25 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2014-07-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD, DIRECTOR |
| Manufacturer Street | 2902 DAIRY DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Manufacturer G1 | IKARIA |
| Manufacturer Street | 2902 DAIRY DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53718 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOMAX DSIR (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2014-04-03 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-03 |