MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-16 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[4879116]
Failed no sensor [device issue]. No adverse event [no adverse event]. Case description: this initial non-serious, device case report was received on (b)(6) 2014 from a respiratory therapist (rt) in the united states who emailed ikaria customer care regarding a device issue with inomax dsir number (b)(4). The device was not in use on a patient at the time of the device issue. It was reported that the rt was unable to speak with technical support (ts) nor able to troubleshoot device at time of report. Inomax dsir number (b)(4) was removed from service and returned to ikaria for service evaluation. Investigational results were received on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[12345131]
On (b)(6) 2014, a respiratory therapist (pt) emailed ikaria customer care regarding a device issue with inomax dsir number (b)(4). The device was not in use on a patient at the time of the device issue. It was reported that the rt refused to speak with technical support (ts) and was not willing to troubleshoot. ((b)(4)). Device investigation was completed on (b)(4) 2014. Evaluation summary: inomax dsir number (b)(6) was returned to the manufacturer fro service investigation. The ikaria regional service center (rsc) reviewed the service log and findings confirmed the reported complaint of a failed no sensor alarm and was immediately preceded by a failed low no cell calibration with low point: 1784 counts above the allowed maximum of 655. The rsc investigation experienced the reported complaint of a failed no sensor alarm at bootup, cleared the alarm by performing high and low calibrations and replaced the no cell as a precautionary measure. A full functional test was performed and the device operated according to specifications so it was returned to the device service pool. The root cause for this incident was no calibration low counts above maximum. This condition will be tracked and trended under ikaria's quality system. Case comment: (b)(4)2014: the device was not in use at the time of device issue and did not result in an adverse event; however it is being reported because a similar device issue occurred in the past that resulted in a serious adverse event (refer to mdr number 3004531588-2013-00022).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00031 |
| MDR Report Key | 4013965 |
| Report Source | 05 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-06-27 |
| Date Mfgr Received | 2014-06-27 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2014-08-27 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANE LI, VP |
| Manufacturer Street | 53 FRONTAGE RD. P.O. BOX 9001 |
| Manufacturer City | HAMPTON NJ 08827 |
| Manufacturer Country | US |
| Manufacturer Postal | 08827 |
| Manufacturer Phone | 9082386745 |
| Manufacturer G1 | IKARIA |
| Manufacturer Street | 6603 FEMRITE 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 | 2014-07-16 |
| 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 | 2014-07-16 |