MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-09 for INO BLENDER * manufactured by Ikaria.
[2576204]
Flow control knob on the ino blender would not turn. Had to bag patient until the knob was successfully turned (took 3 healthcare providers trying before successful). Returned to hfjv further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2501105 |
| MDR Report Key | 2501105 |
| Date Received | 2012-03-09 |
| Date of Report | 2012-03-09 |
| Date of Event | 2012-02-23 |
| Report Date | 2012-03-09 |
| Date Reported to FDA | 2012-03-09 |
| Date Added to Maude | 2012-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INO BLENDER |
| Generic Name | BLENDER, NITRIC OXIDE |
| Product Code | MRO |
| Date Received | 2012-03-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IKARIA |
| Manufacturer Address | 2902 DAIRY DR MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-09 |