MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-23 for INOMAX DS (DELIVERY SYSTEM) 10003 manufactured by Ino Therapeutics, Llc/ikaria.
[1349295]
On (b)(6) 2010, a respiratory therapist reports a hissing noise from the back of device inomax ds (b)(4). The respiratory therapist states there was no harm to patient and no adverse event occurred. The device was replaced with another unit.
Patient Sequence No: 1, Text Type: D, B5
[8720002]
A respiratory therapist reports a hissing noise from the back of the device inomax ds (b)(4). Evaluation summary: the investigation of the device is complete and is as follows: the device was confirmed to have a leak that was traced to the pressure switch. The pressure switch was replaced, and it was confirmed the leak stopped and was corrected. The root cause of the incident was a failed pressure switch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2010-00040 |
| MDR Report Key | 1819706 |
| Report Source | 05 |
| Date Received | 2010-08-23 |
| Date of Report | 2010-08-23 |
| Date of Event | 2010-08-16 |
| Date Mfgr Received | 2010-08-16 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2010-08-30 |
| 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 | MARY ZAMSTEIN |
| Manufacturer Street | 6 STATE ROUTE 173 |
| Manufacturer City | CLINTON NJ 08809 |
| Manufacturer Country | US |
| Manufacturer Postal | 08809 |
| Manufacturer Phone | 9082386337 |
| Manufacturer G1 | INO THERAPEUTICS LLC/IKARIA |
| Manufacturer Street | 2820 WALTON COMMONS WEST |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53718 |
| Single Use | 3 |
| Remedial Action | RC |
| 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 | 2010-08-23 |
| 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 | 2010-08-23 |