MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-06-11 for INOVENT 1605-9000-000 manufactured by Datex-ohmeda.
[20240479]
During a functional test of unit, prior to installation at customer site, diss connector separated from end of oxygen hose when 50 psi oxygen pressure was applied. There was no reported injury. Datex-ohmeda's investigation into the reported occurrence is still ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2004-00050 |
| MDR Report Key | 594055 |
| Report Source | 08 |
| Date Received | 2004-06-11 |
| Date of Report | 2004-06-10 |
| Date of Event | 2004-05-12 |
| Report Date | 2004-05-12 |
| Date Mfgr Received | 2004-05-12 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2005-04-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CATHY JOHNSON SPECIALIST |
| Manufacturer Street | OHMEDA DRIVE |
| Manufacturer City | MADISON WI 53707 |
| Manufacturer Country | US |
| Manufacturer Postal | 53707 |
| Manufacturer Phone | 6082211551 |
| Manufacturer G1 | DATEX-OHMEDA (MADISON) |
| Manufacturer Street | OHMEDA DRIVE |
| Manufacturer City | MADISON WI 53707 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53707 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOVENT |
| Generic Name | NITRIC OXIDE DELIVERY SYS |
| Product Code | CBR |
| Date Received | 2004-06-11 |
| Model Number | INOVENT |
| Catalog Number | 1605-9000-000 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 583882 |
| Manufacturer | DATEX-OHMEDA |
| Manufacturer Address | OHMEDA DRIVE MADISON WI 53707 US |
| Baseline Brand Name | * |
| Baseline Generic Name | * |
| Baseline Model No | INOVENT |
| Baseline Catalog No | 1605-9000-000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-11 |