MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-02-16 for INOMAX DS (DELIVERY SYSTEM) 10003 manufactured by Ino Therapeutics Llc/ikaria.
[20953327]
On (b)(6) 2012 a respiratory therapist (rt) reported that inomax ds device (b)(4), while in use on a pt. Gave a service advisory alarm. The rt powered the device down and back on which resolved the alarm condition. The pt was switched to another device and there was no impact to the pt. The device was removed from service by the customer and returned to the company for investigation.
Patient Sequence No: 1, Text Type: D, B5
[21146517]
On (b)(6) 2012 a respiratory therapist (rt) reported that inomax ds device (b)(4), while in use on a pt, gave a service advisory alarm. Investigation was completed on (b)(6) 2012. Evaluation summary: the device investigation is complete and results follow: the root cause is a system error caused by a segmentation fault. This is related to firmware resident on a cpld. This root cause was determined by examination of the service log. The device functioned as designed to interrupt nitric oxide delivery and alarm when such an error is detected. The main circuit board was replaced and the device function to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2012-00001 |
| MDR Report Key | 2472960 |
| Report Source | 05 |
| Date Received | 2012-02-16 |
| Date of Report | 2012-02-16 |
| Date of Event | 2012-01-14 |
| Date Mfgr Received | 2012-01-26 |
| Device Manufacturer Date | 2009-11-02 |
| Date Added to Maude | 2012-08-20 |
| 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 | 2012-02-16 |
| 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 | 2012-02-16 |