MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2015-06-02 for CURAPLEX MRI PEEP W/ TRANSPORT CIRCUIT 301-1004SP manufactured by Ventlab.
[5831629]
The manifold came apart during use on a pt so there was no flow.
Patient Sequence No: 1, Text Type: D, B5
[13390747]
This is the first complaint for this product family with similar failure mode. The returned product was visually inspected and it was confirmed that the peep valve broke apart. We performed an investigation of inventory and the product performed as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246980-2015-00011 |
| MDR Report Key | 4814474 |
| Report Source | 07,08 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-30 |
| Date of Event | 2015-02-17 |
| Date Mfgr Received | 2015-02-17 |
| Date Added to Maude | 2015-06-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 2710 NORTHRIDGE DRIVE NW STE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598373 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURAPLEX MRI PEEP W/ TRANSPORT CIRCUIT |
| Product Code | BYE |
| Date Received | 2015-06-02 |
| Returned To Mfg | 2015-04-07 |
| Model Number | 301-1004SP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB |
| Manufacturer Address | GRAND RAPIDS MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-02 |