MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-24 for BREATHTECH HS34051 manufactured by Ventlab Llc..
[41417591]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[41417592]
Nurse was at a premature baby delivery and the baby needed to be bagged. Bag would not function properly. Nurse had to quickly grab neo puff and switch face mask to it. Also the manometer went all the way up and it got stuck there.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2015-00027 |
| MDR Report Key | 5523975 |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-24 |
| Date of Event | 2016-02-26 |
| Date Facility Aware | 2016-02-26 |
| Date Added to Maude | 2016-03-24 |
| 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 | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598350 |
| Manufacturer G1 | VENTLAB LLC. |
| Manufacturer Street | 2710 NORTHRIDGEDR. 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 | BREATHTECH |
| Generic Name | RESUSCITATOR,MANUAL,NON SELF-INFLATING |
| Product Code | NHK |
| Date Received | 2016-03-24 |
| Model Number | HS34051 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB LLC. |
| Manufacturer Address | 2710 NORTHRIDGEDR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-24 |