MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-03-31 for INOVENT * 1605-9200-000 manufactured by Ge Healthcare.
[15557975]
The unit reportedly shutdown while on a pt and alarmed. The unit is designed with a back up system, however, it was reportedly improperly connected. The pt experienced a decrease in oxygen saturation. Investigation/conclusion: the unit was returned to the manufacturing site for investigation. During initial testing in the service mode, the no cell reading was noted to be fluctuating rapidly between -5ppm and 150ppm, indicating the no cells is functioning correctly. The unit was then switched to the normal operating mode. The unit shutdown and alarmed "system failure: high no monitored" (due to the fluctuating no reading). The cell cover was removed and the no & no2 cells were inspected. Both cells were found to be approximately 5 years old.
Patient Sequence No: 1, Text Type: D, B5
[15929493]
Cells can be used after the date on the cell, provided they calibrate correctly, and the unit does not alarm, indicating replacement of the cell is required. The cells are user replaceable items and routine testing and calibration is required, as stated in the oepration and maintenance manual. After replacing both the no & no2 cells, the unit operated within mfr's specifications. Additionally, the back up system was tested and verified to be operating correctly. A presure check of the equipment, as stated in the operation and maintenance manual. Should have picked up the condition of expired cells and improperly connected back-up system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2112667-2006-00011 |
| MDR Report Key | 977278 |
| Report Source | 06 |
| Date Received | 2006-03-31 |
| Date of Report | 2006-03-31 |
| Date of Event | 2006-02-27 |
| Date Mfgr Received | 2006-03-03 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2008-01-11 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANN LEBAR |
| Manufacturer Street | 9900 INNOVATION DR MAIL STOP: RP2138 |
| Manufacturer City | WAUWATOSA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal | 53226 |
| Manufacturer Phone | 4147213947 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOVENT |
| Generic Name | NITRIC OXIDE DELIVERY SYSTEM |
| Product Code | CBR |
| Date Received | 2006-03-31 |
| Model Number | * |
| Catalog Number | 1605-9200-000 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 945411 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 3030 OHMEDA DRIVE MADISON WI 53718 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-31 |