MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-08 for VENTLAB HYPERINFLATION BAG SYSTEM HS4011 manufactured by Venlab.
[25881231]
Non self inflating bags broke at the t piece silicone interface.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2015-00019 |
| MDR Report Key | 5061234 |
| Date Received | 2015-09-08 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-08-31 |
| Date Mfgr Received | 2015-08-31 |
| Date Added to Maude | 2015-09-08 |
| 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 | 3 |
| Manufacturer Contact | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | VENLAB |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENTLAB HYPERINFLATION BAG SYSTEM |
| Generic Name | RESUSCITATOR, MANUAL, NON SELF INFLATING |
| Product Code | NHK |
| Date Received | 2015-09-08 |
| Model Number | HS4011 |
| Lot Number | 301564 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENLAB |
| Manufacturer Address | 2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-08 |