MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-27 for CPAP OS manufactured by Emergent Respiratory Products.
[18298874]
Cpap took approximately one minute to initiate airflow upon set up of device and initiation of o2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034786 |
| MDR Report Key | 3660742 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-02-26 |
| Date of Event | 2014-01-08 |
| Date Added to Maude | 2014-03-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPAP OS |
| Generic Name | CPAP OS |
| Product Code | BYE |
| Date Received | 2014-02-27 |
| Model Number | CPAP OS |
| Lot Number | CE8341 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMERGENT RESPIRATORY PRODUCTS |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-27 |