MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-05 for INOMAX DS (DELIVERY SYSTEM) 10003 manufactured by Ino Therapeutics Llc/ikaria.
[2029351]
On (b)(6) 2011, a respiratory therapist (rt) reported that inomax ds (b)(4) was in line with a bunnell high frequency jet ventilator when, after 2 days of use, the nitric oxide (no) readings started fluctuating from -5 to 60 parts per million. The device was removed from use and replaced with a different unit. No adverse event was reported. The customer contacted (b)(4) technical support and the device was cycled on and a low calibration was performed. The device passed the low calibration; however, the rt requested the device be replaced. The device was removed from service by the customer and returned to the company for investigation.
Patient Sequence No: 1, Text Type: D, B5
[9107366]
On (b)(6) 2011, a respiratory therapist (rt) reported fluctuating nitrous oxide readings from -5 to 60 parts per million on the inomax ds (b)(4). Investigation results received on (b)(4) 2011. Evaluation summary: on investigation of the device service log, fluctuating monitored nitric oxide (no) values were recorded. Since fluctuating monitored nitrous oxide 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 nitrous oxide values. It is important to note that the monitored nitrous oxide value would be fluctuating in this case and not the actual nitrous oxide delivered.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2011-00022 |
| MDR Report Key | 2081998 |
| Report Source | 05 |
| Date Received | 2011-04-05 |
| Date of Report | 2011-04-05 |
| Date of Event | 2011-01-13 |
| Date Mfgr Received | 2011-01-13 |
| Device Manufacturer Date | 2010-09-01 |
| 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 DRIVE |
| 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 | 2011-04-05 |
| 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 | 2011-04-05 |