MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-28 for INOMAX DS (DELIVERY SYSTEM) 10003 manufactured by Ino Therapeutics Llc/ikaria.
[1849350]
On (b)(6) 2011, a respiratory therapist reported fluctuating nitric oxide (no) monitored values on the inomax (b)(4). The device was alarming "high no (nitric oxide) / low no (nitric oxide)" while on a patient. The rt stated there was no impact to the patient and no adverse event occurred. Ikaria technical support was contacted; however, the issue could not be resolved. The device was replaced with another unit. The device was removed from service by the customer and returned to the company for investigation.
Patient Sequence No: 1, Text Type: D, B5
[9182051]
Investigation results received on 03/07/2011. Evaluation summary: the root cause of the delivery failure involves fretting corrosion of conducting traces in an internal ribbon cable. The fretting corrosion can cause intermittent high resistance connection to the cable's connector, causing fluctuating monitored (nitric oxide) readings. The internal ribbon cable was replaced and it was confirmed the fluctuating monitored nitric oxide readings stopped and were corrected. It is important to note that the monitored nitric oxide level would be fluctuating in this case and not the actual nitric oxide delivered.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2011-00017 |
| MDR Report Key | 2065972 |
| Report Source | 05 |
| Date Received | 2011-03-28 |
| Date of Report | 2011-03-28 |
| Date of Event | 2011-02-27 |
| Date Mfgr Received | 2011-02-27 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2012-02-17 |
| 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 | 2011-03-28 |
| 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 | 2011-03-28 |