MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-01 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[21728251]
Device would not boot up to a delivery failure alarm every time it was powered on [device issue]. Case description: on (b)(6) 2013 medsun (mandatory and voluntary report) (b)(4) was received by ikaria from the fda. It reported that inomax dsir (b)(4) "would not turn on correctly". Additional info was obtained from the medsun reporter on (b)(6) 2013 and is included in this report. On (b)(6) 2013, the office of clinical safety of a hosp in the united states filed a voluntary medsun report to the fda regarding inomax dsir (b)(4). The reporter stated that, on (b)(6) 2013, "the device would boot up to a device failure alarm every time it was powered on". The reporter also stated that ikaria technical support was contacted and the device was picked up by ikaria for service. There was no mention of the device being on a pt at the time of the delivery failure or if there was any impact to the pt. A search of the ikaria safety database revealed no safety reports from this facility during the time frame indicated on the medsun report. A search of the ikaria complaint reporting database revealed a complaint received by the ikaria customer care (cc) from this hosp on (b)(6) 2013 ((b)(4)). The respiratory therapist (rt) spoke with ikaria technical support and reported that inomax dsir (b)(4) had a delivery failure. He stated that the device was on a pt and functioned as expected. Ino therapy was discontinued and when a decision was made to restart therapy, the device was turned on and went into delivery failure. The rt reported that the device was not on a pt, therefore, there was no harm to the pt. The device was switched out with a new inomax dsir device (serial# not provided) and inomax dsir (b)(4) was removed from service. The rt stated that the device was tested again and would continuously reboot to delivery failure. The device was returned to ikaria for inspection. On (b)(6) 2013 the medsun reporter provided additional info. The pt was a (b)(6) male with a cardiac disorder not otherwise specified (nos) scheduled for cardiac surgery on (b)(6) 2013. Other medical history, type of cardiac surgery scheduled and concomitant medications were not provided. In preparation for cardiac surgery, the pt was started on inomax at 20 parts per million (ppm) on (b)(6) 2013 via the inomax dsir (b)(4). The device was functioning without problems on the pt. The rt and nurse prepared the pt for transport to the operating room, removed him from the ventilator and the inomax dsir, and initiated manual ventilation with the inoblender using oxygen and inomax at 20 ppm. The rt was then told to hold the pt in the intensive care unit a bit longer while the operating room was readied, so a decision was made to restart the pt on the ventilator and the inomax dsir. During this time, the pt was being continuously ventilated with the inoblender while the ventilator and inomax dsir were readied for use. When the inomax dsir was turned back on, it alarmed delivery failure. Since the pt was being manually ventilated with the inoblender, there was no harm to the pt. The pt was transported to the operating room where a new inomax dsir was set up for use (serial number not provided). The new inomax dsir functioned without problems. Inomax dsir (b)(4) was removed from service and the rt training educator called ikaria technical support on (b)(6) 2013 to discuss the issue. A decision was made to return the device to ikaria for inspection.
Patient Sequence No: 1, Text Type: D, B5
[21894663]
Medsun report (b)(4) received from the fda on 09-jul-2013 reported that inomax dsir (b)(4) "would not turn on correctly". Eval summary: the inomax dsir device was returned to the mfr for service investigation. Review of the service log confirmed the reported delivery failure. The device continued to display delivery failure when powered up. Upon troubleshooting the device, a broken pin connection on the internal injector module cable receptacle ground wire was found. The internal injection module cable was replaced and a full functional test of the device was then performed. The device passed all tests in accordance with specifications and was returned to the device pool for distribution. This condition will be tracked and trended under ikaria's quality system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2013-00017 |
| MDR Report Key | 3282848 |
| Report Source | 05 |
| Date Received | 2013-08-01 |
| Date of Report | 2013-07-09 |
| Date Mfgr Received | 2013-07-09 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2013-09-04 |
| 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 | 2013-08-01 |
| 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 | 2013-08-01 |