MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-24 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[4269490]
Failed nitric cell [device issue]. No adverse event [no adverse event]. Case description: on (b)(6) 2014 medsun safety report (b)(4) was received by ikaria from the fda. The report stated that the inomax dsir (b)(4) 'alarmed failed nitric cell. " on (b)(6) 2014 the office of clinical safety at a hospital in the united states filed a voluntary medsun report with the fda regarding the inomax dsir (b)(4). The report stated that on (b)(6) 2013, "inovent alarming 'failed nitric cell' and was switched out with another inovent. Upon inspection, the device generated a 'no cell failure' alarm while in use. The device was low and high level calibrated, performance checked and returned to service. Per ikaria tech support, the 2 point calibration slope drifted and required the low/high level calibrations to bring it back into range. " there was no impact to the patient noted on the medsun report. The device in question was listed on the medsun report as an inovent; however the serial number provided by the site is assigned to an inomax dsir unit. Furthermore, the device was identified by the reporter as an inomax dsir in the model number field of the medsun report. A search of the ikaria safety database revealed no associated complaints for the inomax dsir (b)(4) from the reporting hospital during the time frame indicated on the medsun report. A search of the ikaria complaint reporting database revealed a complaint received by ikaria technical support from this hospital on (b)(6) 2013 (b)(4). The rt training educator called to report that the inomax dsir (b)(4) had alarmed failed nitric cell and after performing the low calibration and no high calibration on the device the alarm message cleared. The rt wanted to confirm that the device was functioning correctly and could be put back into service. After discussing the calibrations with the rt, ikaria technical services confirmed that the device issue had resolved and the device was functioning properly. At the time of the rt's call, the device was not in use on a patient and the rt did not mention that the device had previously been on a patient. The problem was resolved and the device was not returned to ikaria for inspection.
Patient Sequence No: 1, Text Type: D, B5
[11618255]
On (b)(6) 2014 medsun safety report (b)(4) was received by ikaria from the fda. The report stated that the inomax dsir (b)(4) "alarmed failed nitric cell" (complaint-(b)(4)). Evaluation summary: this mdr is filed in response to receipt of a copy of a user mdr, (b)(4), from (b)(4), as is ikaria's practice. There was no adverse event associated with the reported device issue. The device was returned to the hospital's respiratory department for inspection. After both a high calibration and low calibration were performed, the device functioned per expectations. The rt training educator contacted ikaria technical support to discuss the actions taken with the device prior to returning the device to use in the facility. Based on the information provided, the root cause for the incident was the device required recalibration.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00005 |
| MDR Report Key | 3697359 |
| Report Source | 05 |
| Date Received | 2014-02-24 |
| Date of Report | 2014-02-10 |
| Date Mfgr Received | 2014-02-10 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2014-03-27 |
| 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 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 | MRQ |
| Date Received | 2014-02-24 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-24 |