MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-19 for VENTLAB HYPERINFLATION SYSTEM FEATURING BUILT IN PRESSURE MONITOR HS4051 HS 4000 SERIES manufactured by Ventlab Corporation.
[65833934]
During a simulator event, the physician was "bagging" the infant simulator and the disposable anesthesia bag ruptured. The bag was over inflated, the flow through the bag from the o2 source was between 10-15 lpm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067432 |
| MDR Report Key | 6275708 |
| Date Received | 2017-01-19 |
| Date of Report | 2017-01-19 |
| Date of Event | 2017-01-11 |
| Date Added to Maude | 2017-01-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENTLAB HYPERINFLATION SYSTEM FEATURING BUILT IN PRESSURE MONITOR |
| Generic Name | VENTLAB HYPERINFLATION SYSTEM FEATURING BUILT IN PRESSURE MONITOR |
| Product Code | NHK |
| Date Received | 2017-01-19 |
| Model Number | HS4051 |
| Catalog Number | HS 4000 SERIES |
| Lot Number | 303501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB CORPORATION |
| Manufacturer Address | MOCKSVILLE NC 27028 US 27028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-19 |