MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for VENT LAB 87-AF1040MCT-I manufactured by Sunmed, Llc.
[66702882]
Ambu bag broke off where the mask attaches to ambu bag; resulting in need to obtain second bag during code blue situation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6305157 |
| MDR Report Key | 6305157 |
| Date Received | 2017-02-06 |
| Date of Report | 2017-02-02 |
| Date of Event | 2017-01-20 |
| Date Facility Aware | 2017-01-23 |
| Report Date | 2017-02-02 |
| Date Reported to FDA | 2017-02-02 |
| Date Added to Maude | 2017-02-06 |
| 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 | 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 | VENT LAB |
| Generic Name | RESUSCITATION DEVICE BVM-AMBU BAG |
| Product Code | NHK |
| Date Received | 2017-02-06 |
| Catalog Number | 87-AF1040MCT-I |
| Lot Number | 306795 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED, LLC |
| Manufacturer Address | GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-06 |