MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-11-19 for INOBLENDER (BACKUP DELIVERY SYSTEM) manufactured by Ikaria.
[4124500]
Inoblender not set up correctly to inomax device [device misuse]. O2 destats [oxygen saturation decreased]. "pt didn't do very well" [general physical health deterioration]. Case description: this initial post marketing spontaneous case report was received on (b)(4) 2013 from a clinical educator respiratory therapist (rt) in the united states who reported that about 3 years ago a "(b)(6) on inomax did poorly" while being manually ventilated because the inoblender hose was not connected to the inomax device. Follow up information obtained on (b)(4) 2013 is included in this report.
Patient Sequence No: 1, Text Type: D, B5
[11458383]
This initial post marketing spontaneous case report was received on (b)(4) 2013 from a clinical educator respiratory therapist (rt) in the united states who reported that about 3 years ago an adverse event occurred when the inoblender hose was not connected to the inomax device during manual ventilation with the inoblender. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2013-00026 |
| MDR Report Key | 3529735 |
| Report Source | 05,07 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-10-24 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2013-10-24 |
| Date Added to Maude | 2014-01-09 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD, DIR |
| 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 | INOBLENDER (BACKUP DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE, BACKUP DELIVERY |
| Product Code | MRO |
| Date Received | 2013-11-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-19 |