MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-04 for INOMAX DS (DELIVERY SYSTEM) 10003 manufactured by Ino Therapeutics Llc/ikaria.
[1977803]
On (b)(6) 2011, a respiratory therapist (rt) reported fluctuation in the nitric oxide (no) readings on inomax ds (b)(4). The respiratory therapist stated that the device passed a low calibration but once the device was put on the pt the no readings started fluctuating. The pt was removed from the device. The rt stated there was no harm to pt and no adverse event occurred. The rt did a low calibration, a high calibration and a performance check, however, the no was still reading higher and lower than settings. The device was replaced with another unit delivered later that day. Inomax (b)(4) was removed from service by the customer and returned to the company for investigation.
Patient Sequence No: 1, Text Type: D, B5
[9187887]
On (b)(6) 2011, a respiratory therapist reported fluctuation in the nitric oxide (no) on inomax ds (b)(4). Investigation results received on (b)(4) 2011. Eval summary: on investigation of the device service log, fluctuating monitored nitric oxide (no) values were recorded. Since fluctuating monitored no values have been observed in the service logs of other devices and have been linked to fretting corrosion of an internal ribbon cable, the cable was replaced. Following cable replacement, the device performed to specifications. The fretting corrosion can lead to intermittent high resistance connection at the cable's connector, leading to fluctuating monitored no values. It is important to note that the monitored no value would be fluctuating in this case and not the actual no delivered.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2011-00019 |
| MDR Report Key | 2079661 |
| Report Source | 05 |
| Date Received | 2011-04-04 |
| Date of Report | 2011-04-04 |
| Date of Event | 2011-01-20 |
| Date Mfgr Received | 2011-01-20 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2012-02-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD |
| Manufacturer Street | 2902 DAIRY DR. |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOMAX DS (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2011-04-04 |
| Model Number | 10003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INO THERAPEUTICS LLC/IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-04 |