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.
[16086964]
Failed no sensor (device issue). No adverse event. 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 ikaria technical services (ts) regarding a device issue with inomax dsir (b)(4). The device was in use on a patient at the time of the device issue and the reporter stated that no harm occurred to the patient. It was reported that the rt called to report a device issue with inomax dsir (b)(4) while on a patient and had experienced an alarm condition failed no sensor. The set up was reviewed with the reporter and found to be correct. All connections were also checked and found to be tight. A high range calibration to nitric oxide fuel cell followed by a low range calibration was performed on the device which resulted in a previous alarm condition message failed no sensor. The reporter stated no harm occurred to the patient. Inomax dsir (b)(4) was removed from service and returned to ikaria for service eval. Investigational results were received on (b)(4) 2014. On (b)(4) 2014: this device case 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 # 3004531588-2013-00022).
Patient Sequence No: 1, Text Type: D, B5
[16312635]
On (b)(6) 2014 a respiratory therapist (rt) called ikaria technical services (ts) regarding a device issue with inomax dsir (b)(4). The device was in use on a patient at the time of the device issue and no harm occurred to the patient ((b)(4)). Device investigation was completed on (b)(4) 2014. Inomax dsir (b)(4) was returned to the mfr for service investigation. The ikaria regional service center (rsc) reviewed the service log and findings confirmed the reported complaint of a failed no sensor alarm. The failed no sensor alarm immediately followed a failed low no calibration with low point: ((b)(4)) counts above the allowed maximum of (b)(4). A further log review revealed a delivery failure (df) alarm for no > 100 ppm while delivering 5 ppm no with avg=4. 5 cur=1. 5 lpm im flow and delivering 0 ppm no with avg=5. 4 cur=1. 4 lpm im flow. Both df alarms occurred less than 9 minutes before the failed no sensor alarm and are consistent with a misbehaving no cell. The rsc investigation also experienced a failed no sensor alarm at bootup, performed low and high calibrations to clear the alarm and replaced the no sensor 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. This case did not result in an adverse event; however, it is being submitted to reg authorities because a similar failure occurred in the past which resulted in a serious adverse event (mdr 3004531588-2013-00022).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00032 |
| MDR Report Key | 4013960 |
| Report Source | 05 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-07-01 |
| Date Mfgr Received | 2014-07-01 |
| Device Manufacturer Date | 2009-11-01 |
| 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 | PERRYVILLE III CORP PARK, 53 FRONTAGE RD PO 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 |