MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-25 for VENTLAB HYPERINFLATION BAG SYSTEM HS4011 manufactured by Ventlab.
[24805885]
Two 1l self inflating bags had broken during intubation. One broke as rt was putting the mask on the bag and the second broke after the mask was on the bag. The bags both broke where it connects to the mask/ett.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2015-00017 |
| MDR Report Key | 5027883 |
| Date Received | 2015-08-25 |
| Date of Report | 2015-08-25 |
| Date of Event | 2015-07-11 |
| Date Mfgr Received | 2015-08-12 |
| Date Added to Maude | 2015-08-25 |
| 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 | MR. ROB YAMASHITA |
| Manufacturer Street | 2710 NORTHRIDGE DR. NW - STE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598373 |
| Manufacturer G1 | VENTLAB |
| Manufacturer Street | 2710 NORTHRIDGE DR. NW - STE 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 | 3 |
| Brand Name | VENTLAB HYPERINFLATION BAG SYSTEM |
| Generic Name | RESUSCITATOR,MANUAL,NON SELF-INFLATING |
| Product Code | NHK |
| Date Received | 2015-08-25 |
| Model Number | HS4011 |
| Lot Number | 301564 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB |
| Manufacturer Address | 2710 NORTHRIDGE DR. NW - STE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-25 |