MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-16 for PORTO2VENT 1099-001 manufactured by Sarnova.
[2148670]
Ambulance called to scene of a patient in respiratory distress. The paramedics began care and found that their continuous positive airway pressure (cpap) unit failed to work when plugged into the oxygen wall outlet in the back of the ambulance. When it finally started to work, there was too much air leaking at the site of where the mask tubing hooks in. The ambulance crew members were unable to get adequate pressure to make any difference. No adverse effect to patient. The unit was pulled from service and sent to biomedical engineering. Follow-up action: the unit was tested and no problem was found. The unit was returned to service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2108050 |
| MDR Report Key | 2108050 |
| Date Received | 2011-05-16 |
| Date of Report | 2011-05-13 |
| Date of Event | 2011-04-30 |
| Report Date | 2011-05-13 |
| Date Reported to FDA | 2011-05-16 |
| Date Added to Maude | 2011-05-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTO2VENT |
| Generic Name | CPAP |
| Product Code | BZD |
| Date Received | 2011-05-16 |
| Model Number | 1099-001 |
| Catalog Number | 1099-001 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SARNOVA |
| Manufacturer Address | 5000 TUTTLE CROSSING BLVD DUBLIN OH 43016 US 43016 |
| Brand Name | CPAP OS BREATHING CIRCUIT |
| Generic Name | BREATHING CIRCUIT, MASK |
| Product Code | BYE |
| Date Received | 2011-05-16 |
| Model Number | 35204-008 |
| Catalog Number | 35204-008 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SARNOVA |
| Manufacturer Address | 5000 TUTTLE CROSSING BOULEVARD DUBLIN OH 43016 US 43016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-16 |