MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-05 for AMBU BAG MASK manufactured by Ventlab, Llc.
[48743188]
Patient Sequence No: 1, Text Type: N, H10
[48743189]
Ambu bag mask did not have air in it. Unable to put air in mask. No expiration date listed, manufacture date of about a month ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5768636 |
| MDR Report Key | 5768636 |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-30 |
| Date of Event | 2015-10-27 |
| Report Date | 2016-06-30 |
| Date Reported to FDA | 2016-06-30 |
| Date Reported to Mfgr | 2016-06-30 |
| Date Added to Maude | 2016-07-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | AMBU BAG MASK |
| Generic Name | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
| Product Code | NHK |
| Date Received | 2016-07-05 |
| Lot Number | 302505 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB, LLC |
| Manufacturer Address | 2710 NORTHRIDGE DRIVE SW SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-05 |