MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-07 for VENTLAB HS4051 manufactured by Ventlab Llc..
[69571407]
The affected product was not returned for evaluation. The end user reported the oxygen flow from the o2 source was between 10 - 15 lpm at the time of the reported overinflation however the ifu specifically states 'connect tubing to oxygen source and adjust flow initially to 8 lpm. ' this failure is presumably the result of inappropriate use and not due to defective product. This is the first time this product failure has been reported.
Patient Sequence No: 1, Text Type: N, H10
[69571408]
The customer alleges "during a simulator event the anesthesia bag ruptured and was overinflated.. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2017-00013 |
| MDR Report Key | 6384407 |
| Date Received | 2017-03-07 |
| Date of Report | 2017-02-07 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-02-07 |
| Date Added to Maude | 2017-03-07 |
| 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 | 6162598400 |
| Manufacturer G1 | VENTLAB |
| Manufacturer Street | 2710 NORTHRIDGE DR. 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 | HYPERINFLATION SYSTEM |
| Product Code | NHK |
| Date Received | 2017-03-07 |
| Model Number | HS4051 |
| Lot Number | 30351 |
| 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 | 2017-03-07 |