MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-15 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[4425793]
Delivery failure [device issue]. No adverse event [no adverse event]. Case description: this initial non-serious, device case report was received on 03/12/2014 from a health professional representative in picu (interpreted as pediatric intensive care unit) in the united states who called to speak with ikaria technical services regarding a device issue with inomax dsir number (b)(4). The device was in use on a patient at the time of the device issue, and per the healthcare professional from picu, there was no harm to the patient. On (b)(6) 2014, a healthcare professional representative from picu reported a delivery failure alarm on inomax dsir number (b)(4). Ikaria's technical services offered to troubleshoot, but the healthcare professional representative from picu was not willing to troubleshoot and requested that the device be picked up; no further information was provided. Inomax dsir number (b)(4) was removed from service and returned to ikaria for service evaluation.
Patient Sequence No: 1, Text Type: D, B5
[11998208]
On (b)(6) 2014, a health professional representative in picu (interpreted as pediatric intensive care unit) called to speak with ikaria technical services regarding a device issue with inomax dsir number (b)(4). The device was in use on a patient at the time of the device issue, and per the healthcare professional from picu, there was no harm to the patient. ((b)(4)). Device investigation was completed on 05/06/2014. Evaluation summary: inomax dsir serial number (b)(4) was returned to the manufacturer for service investigation. The ikaria regional service center (rsc) reviewed the service log and findings confirmed the reported complaint of a delivery failure (df) alarm. The rsc performed the performance test at 10 ppm and 40 ppm with a flow at 10l/min; passed, monitored 11 pm and 44 ppm; no delivery failures were generated. The im and cable were not returned for investigation. The rsc replaced the shut-off valve due to the service log delivery failure alarm with mp shutoff valve shut < 0. 15 slpm and replaced the proportional valve due to delivery failure alarm with control valve shut < 0. 15 slpm. A full functional test was performed and the device operated according to specifications so it was returned to the device service pool. These conditions will be tracked and trended under ikaria's quality system. This case did not result in an adverse event; however it is being submitted to regulatory authorities because the proportional valve failure has occurred in the past and resulted in a serious event (mdr 3004531588-2013-00013).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00020 |
| MDR Report Key | 3884140 |
| Report Source | 05 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-05-06 |
| Date Mfgr Received | 2014-05-06 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2014-07-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | 2014-05-15 |
| 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 | 2014-05-15 |