MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-19 for INOVO 3000380-16 * manufactured by Inovo.
[16414594]
While transporting the patient in the elevator from er to sicu the patient's spo2 pulse oximeter oxygen saturation dropped to 78%. Upon arrival to the correct bed in sicu, the sicu nurse was attempting to disconnect the oxygen tubing from the tank and connect it to the wall oxygen. When she did this the oxygen flow meter came apart into 4 pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911519 |
| MDR Report Key | 1911519 |
| Date Received | 2010-10-19 |
| Date of Report | 2010-10-07 |
| Date of Event | 2010-10-04 |
| Report Date | 2010-10-07 |
| Date Reported to FDA | 2010-10-19 |
| Date Added to Maude | 2010-12-01 |
| 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 |
| 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 | INOVO |
| Generic Name | "E" CYLINDER OXYGEN FLOWMETER |
| Product Code | CAX |
| Date Received | 2010-10-19 |
| Model Number | 3000380-16 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INOVO |
| Manufacturer Address | 2975 HORSESHOE DRIVE #600 NAPLES FL 34104 US 34104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-19 |