MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-28 for INOMAX DS (DELIVERY SYSTEM) 10007 manufactured by Ikaria..
[4090908]
Battery failure with device shut down [device battery issue]. Near respiratory arrest [acute respiratory failure]. Bradycardia [bradycardia]. Increase in pulmonary artery pressure [pulmonary arterial pressure increased]. Hypotension [hypotension]. Case description: this initial serious spontaneous case report was received on (b)(6) 2013 from a respiratory therapist in the united states reporting a "battery failure and device shut down with the inomax dsir (b)(4) while on a pt resulting in the need for intubation". Follow up information received on (b)(6) 2014 is included in this report. Relevant medical history/co-morbidities: (b)(6) female pt with severe pulmonary hypertension. Relevant concomitant medications: intravenous flolan. Inomax was administered to an adult pt by the inomax dsip (b)(4) at 20 parts per million (ppm) via high flow (35 l/min oxygen) nasal cannula for severe pulmonary hypertension. The start date inomax was 2-3 days prior to the device issue which occurred on (b)(6) 2013. The rt reported the pt was responding well to ino therapy. On (b)(6) 2013, the inomax dsir alarmed battery failure and the device went into delivery failure. Within 10 - 15 seconds after the delivery failure the pt became bradycardiac, hypotensive, pulmonary artery pressures (pap) increased with a "near respiratory arrest". According to the rt the pt required immediate intubation and resuscitative measures including vasopressors and/or inotropic medications (nos). After intubation, the pt was manually ventilated on 100% oxygen and inomax via the inoblender and stabilized quickly. The pt was ventilated with the inoblender for about 15 minutes while the puritan bennett 840 ventilator and back up inomax dsir (serial number not provided) were set up. The pt remained stable once connected to the ventilator and inomax dsir. The rt could not provide baseline heart rate, blood pressure or pap pressures or values during device issue. The inomax dsir (b)(4) was removed from service and returned to (b)(6) for inspection. The rt reported to (b)(6) that the battery failure and device shut down "may have been user error on our part because the electrical outlet may have had a short in it and was not charging the battery; this was found when another device was plugged into the outlet". The rt considers the events of bradycardia and increase in pap as life threatening due to the need for immediate intubation. The rt did not assess or provide additional information about the events of hypotension and near respiratory arrest.
Patient Sequence No: 1, Text Type: D, B5
[11659180]
(b)(4). Inomax dsir (b)(4) is under investigation. A supplemental report will be submitted within 30 days of completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00002 |
| MDR Report Key | 3609005 |
| Report Source | 05 |
| Date Received | 2014-01-28 |
| Date of Report | 2013-12-30 |
| Date of Event | 2013-12-27 |
| Date Mfgr Received | 2013-12-30 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2014-02-06 |
| 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, DIRECTORY |
| 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 DIARY 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 DS (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2014-01-28 |
| 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 | 2014-01-28 |