MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-11 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[3883670]
Device screen blank [device malfunction]. Oxygen desaturation from 92% to 72% - 71% [oxygen saturation decreased]. Heart rate decreased from 122 bpm to 81-95 bpm [heart rate decreased]. Case description: on (b)(6) 2013 a respiratory therapist (rt) in the united states called to report a "blank screen" on the inomax dsir (b)(4) while in use on a pt who experienced an oxygen desaturation. F/u info obtained on (b)(6) 2013 is included in this report. Relevant medical history: male neonate born on (b)(6) 2013 with meconium aspiration and hypoxic ischemic event. Concomitant medications include: dopamine, norcuron (vecuronium), morphine iv and versed (midazolam) iv. The pt was intubated and on the sensormedics 3100a high frequency oscillatory ventilator with the following settings: frequency 9 hertz, amplitude 38, mean airway pressure 15 cm h2o and fractional inspired oxygen concentration (fio2) 0. 94. On (b)(6) 2013 at 09:46 the pt was started on inomax at 20 parts per million via the inomax dsir (b)(4) for pulmonary hypertension. The rt reported that on (b)(6) 2013 the inomax dsir "screen was dimmer than usual" (brightness and contrast settings were set to 5) and at 06:35 the device screen went black/blank and the device alarmed. The touch screen functioning and alarms were able to be silenced however then device screen was still black. Nursing care (not specified) was being provided to the pt prior to the device issue. The rt reports that approx 90 seconds after device screen went black the pt's oxygen saturation levels began to decline quality from 92% to 72% - 71%. The device was cycled to standby and on several times by rt prior to calling ikaria. The cylinder valve was closed and no drop in psi was observed. The valve was opened and the back-up delivery mode was initiated. Then the pt was manually ventilated with the inoblender which resulted in oxygen saturation improvement from 71% to 80%. Manual ventilation continued for 20 mins while the back up device was prepared for use. His heart rate decreased from a baseline of 122 beats per min (bpm) to 81 to 95 bpm lasting 20 mins in duration and returning to baseline at approx 06:57. At 07:05 the pt was placed back on ino therapy with a new dsir and this oxygen saturation returned to baseline. The rt stated that the event of oxygen saturation from 92% to 71% for 20 mins was life threatening and probably related to the inomax dsir blank screen problem. The inomax dsir (b)(4) was removed from service and returned to ikaria for inspection.
Patient Sequence No: 1, Text Type: D, B5
[11154694]
On (b)(6) 2013 a respiratory therapist (rt) in the united states called to report a "blank screen" on the inomax dsir (b)(4) while in use on a pt. (b)(4). Eval summary: the device was returned to the mfr for svc investigation. Eval of the svc log revealed several instances of delivery failure alarms due to low current in the display backlight which is consistent with the user report that the display went blank/black. The display subassembly was replaced to address the issue of the low display backlight current observed in the log. A full functional test was performed and the device operated according to the specifications so it was returned to the device svc pool. The root cause for this incident was a malfunction of the display subassembly installed in the device. This condition will be tracked and trended under ikaria's quality system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2013-00023 |
| MDR Report Key | 3415767 |
| Report Source | 05 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-09-22 |
| Date of Event | 2013-09-22 |
| Date Mfgr Received | 2013-09-22 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2013-10-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD, DIR |
| Manufacturer Street | 2902 DAIRY DR. |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Manufacturer G1 | IKARIA |
| Manufacturer Street | 2902 DAIRY DR. |
| 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 | 2013-10-11 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Life Threatening; 2. Other | 2013-10-11 |