MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-21 for SUNMED VENTLAB PEEP VALVE VP703 manufactured by Vent Lab Llc / Sunmed Holdings, Llc.
| Report Number | MW5089263 |
| MDR Report Key | 8922997 |
| Date Received | 2019-08-21 |
| Date of Report | 2019-08-05 |
| Date of Event | 2019-08-01 |
| Date Added to Maude | 2019-08-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUNMED VENTLAB PEEP VALVE |
| Generic Name | ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE |
| Product Code | BYE |
| Date Received | 2019-08-21 |
| Model Number | VP703 |
| Catalog Number | VP703 |
| Lot Number | 318781 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENT LAB LLC / SUNMED HOLDINGS, LLC |
| Manufacturer Address | 2710 NORTHRIDGE DR NW, STE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-08-21 |