MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-23 for DRV VALVE 3011 UNK manufactured by Nova Ventrx, Inc..
[62651]
Pt with diagnosis of sigmoid colon cancer admit for resection. Needle biopsy of liver revealed metastasis. Procedure completed & pt moved form table to bed. Anesthesia machine disconnected. Anesthesiologist attempted to hand ventilate w/ambu bag, expiratory valve appeared stuck closed. Bag changed but pt became cyanotic and bradycardiac. Further resuscitation was unsuccessful and pt expired at 1445. Ambu bag and valve sent to outside co for objective analysis. No report as yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 100393 |
| MDR Report Key | 100393 |
| Date Received | 1997-06-23 |
| Date of Report | 1997-06-23 |
| Date of Event | 1997-06-10 |
| Date Facility Aware | 1997-06-10 |
| Report Date | 1997-06-23 |
| Date Added to Maude | 1997-06-26 |
| 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 | DRV VALVE |
| Generic Name | VALVE FOR NON-DISPOSABLE AMBU BAG |
| Product Code | CBP |
| Date Received | 1997-06-23 |
| Model Number | 3011 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 98910 |
| Manufacturer | NOVA VENTRX, INC. |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-06-23 |