MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-09-22 for VENTLAB HYPERINFLATION SYSTEM HS4051 manufactured by Ventlab Llc..
[55423204]
The affected device was found to have a cut or torn bag. In addition, the bag for the hyperinflation system appears to have been cut with a knife in one place and the bag was punctured in three other locations. The investigator's conclusion was that someone used a knife or box cutter to open the shipping box and cut the affected device in the process. This failure mode has neven been seen before by the investigator.
Patient Sequence No: 1, Text Type: N, H10
[55423205]
The customer alleges "the product was torn. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2016-00047 |
| MDR Report Key | 5970730 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-09-22 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2016-08-26 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2016-09-22 |
| 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 | 3 |
| Brand Name | VENTLAB HYPERINFLATION SYSTEM |
| Generic Name | HYPERINFLATION SYSTEM |
| Product Code | NHK |
| Date Received | 2016-09-22 |
| Returned To Mfg | 2016-09-06 |
| Model Number | HS4051 |
| Lot Number | 302719 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-09-22 |