MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-04-04 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ino Therapeutics, Llc/ikaria.
[17557234]
This initial spontaneous report was received on (b)(6) 2012 from a respiratory therapist in the united states regarding a (b)(6) male who experienced device failure (screen malfunction) while on inomax dsir ((b)(4)). No medical history or concurrent conditions were reported. No concomitant medications were reported. The start date of inomax therapy via the inomax dsir was not reported; therapy was provided for an unk indication. On (b)(6) 2012 the inomax dsir screen malfunctioned. No problems were reported concerning the pt. The device was sent to the biomedical engineer in the hospital. The bioengineer reported he could not duplicate the problem and the inomax dsir was put back in service. The reporter stated "the device did not do what it was supposed to do. "
Patient Sequence No: 1, Text Type: D, B5
[17709668]
On (b)(6) 2012 the rt reported the inomax dsir ((b)(4)) had screen malfunction. ((b)(4)). This inomax dsir ((b)(4)) is under investigation. A supplemental report will be submitted within 30 days of completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2012-00004 |
| MDR Report Key | 2520213 |
| Report Source | 00,05 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-04-04 |
| Date of Event | 2012-02-07 |
| Date Mfgr Received | 2012-03-06 |
| Device Manufacturer Date | 2011-11-29 |
| Date Added to Maude | 2012-09-07 |
| 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 DSIR (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2012-04-04 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-04-04 |