MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-01 for SAFETY DRAIN * manufactured by Ballard Medical Products.
[20642]
Cardiopulmonary technician was attempting to suction from a safety drain connected to a circuit on a ventilator. During suction the technician noticed the circuit expand and the exhalation valve alarm and the peek pressure alarm sounded. The circuit was removed for the pt and the pt was bagged. There were not adverse pt outcomes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35534 |
| MDR Report Key | 35534 |
| Date Received | 1996-07-01 |
| Date of Report | 1996-07-01 |
| Report Date | 1996-07-01 |
| Date Added to Maude | 1996-08-20 |
| 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 | SAFETY DRAIN |
| Generic Name | CLOSED CIRCUIT DRAIN |
| Product Code | BYH |
| Date Received | 1996-07-01 |
| Model Number | SAFETY DRAIN |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 36957 |
| Manufacturer | BALLARD MEDICAL PRODUCTS |
| Manufacturer Address | 12050 LONE PEAK PKWY DRAPER UT 840209414 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-07-01 |