MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-17 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[18366675]
Inomax dsir went into delivery failure (device malfunction) failed no sensor alarm following a delivery failure (device malfunction). Case description: this initial non-serious device case report was received on (b)(4) 2014 from a respiratory therapist (rt) in the united states who called to speak with ikaria technical services about a failed no (nitric oxide) sensor alarm following a delivery failure with the inomax dsir (b)(4) while in use on a patient. There was no impact to the patient. Ikaria investigation results were received on (b)(4) 2014. Relevant medical history/co-morbidities: no patient information provided. Relevant concomitant medications: albuterol. The patient was started on an undisclosed date via the inomax dsir (b)(4). The dose of inomax was not provided. The rt reported that on (b)(6) 2014, "while the patient was receiving nebulizer albuterol treatments, the beside rt moved the sample tee and got a delivery failure (alarm) with the inomax dsir, but did not notice the monitor value reach above 100 ppm". The patient was removed from the ventilator and manually ventilated with the inoblender while the inomax dsir was powered off and on to reset the delivery failure alarm. Upon boot up the failed (no) sensor alarm appeared. The bedside rt switched the device off the patient. There was no reported impact to the patient. Once off the patient, the rt performed recalibrations on the inomax dsir (b)(4), but was unable to clear the failed sensor alarm. The device was returned to ikaria for service evaluation. Case comment: (b)(6) 2014: the case did not result in an adverse event, however it is being reported because a similar failure occurred in the past that resulted in a serious adverse event (see mdr#3004531588-2013-00022).
Patient Sequence No: 1, Text Type: D, B5
[18536209]
The initial non-serious case repot was receive on (b)(6) 2014 from a respiratory therapist (rt) in the united states who called to speak with ikaria technical services about a failed no sensor alarm following a delivery failure with the inomax dsir (b)(4) while in use on a patient. There was no impact to the patient. ((b)(4)). The device investigation was completed on (b)(4) 2014. Evaluation summary: the inomax dsir device serial number (b)(4) was returned to ikaria's regional service center (rsc) for service evaluation. Examination of the service log confirms the reported complaints of delivery failure alarm while delivery 16ppm no with acceptable injector module flow and failed no cell alarms. The log also reveals a failed low no calibration with elevated low point counts above the maximum allowable counts and preceding no of 62 ppm consistent with a failing no cell. The failing no cell as evidenced by the failed low no calibration with elevated low point counts could have contributed tot he delivery failure alarm. The rsc investigation experienced both the deliver failure and failed no sensor alarms, and the no cell was replaced. The zero valve was also replaced as a precaution. The root cause for the incident wa no cal low counts above maximum. This condition will be tracked and trended under ikaria's quality system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00006 |
| MDR Report Key | 3832852 |
| Report Source | 05 |
| Date Received | 2014-03-17 |
| Date of Report | 2014-03-11 |
| Date Mfgr Received | 2014-03-11 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2014-06-18 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD |
| 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 | MRP |
| Date Received | 2014-03-17 |
| 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 | 2014-03-17 |