MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for VENTLAB 95788 manufactured by Ventlab Llc..
[68212196]
The investigation of this defect was inconclusive. This is the first time that this type of complaint has been received and the affected device wasn't returned for evaluation. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[68212197]
The customer alleges "the endotracheal tube was difficult to remove from the hyperinflation valve. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2017-00008 |
| MDR Report Key | 6346977 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-01-23 |
| Date of Event | 2016-12-06 |
| Date Added to Maude | 2017-02-21 |
| 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 | VENTLAB |
| Generic Name | HYPER MANOMETER WITH POP-OFF VALVE |
| Product Code | NHK |
| Date Received | 2017-02-21 |
| Model Number | 95788 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-21 |