MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-24 for BOUSSIGNAC CPAP SYSTEM 5562.513 manufactured by Vitaid Vygon.
[2487917]
While placing the cpap mask on a pt, the o2 connection broke off. There was no damage or trauma noted prior to placing the mask on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024437 |
| MDR Report Key | 2474322 |
| Date Received | 2012-02-24 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-02-23 |
| Date Added to Maude | 2012-03-02 |
| 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 | 0 |
| 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 | BOUSSIGNAC CPAP SYSTEM |
| Generic Name | CPAP |
| Product Code | BYE |
| Date Received | 2012-02-24 |
| Catalog Number | 5562.513 |
| Lot Number | 11H37 |
| Device Expiration Date | 2016-02-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAID VYGON |
| Manufacturer Address | DOVER NH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-02-24 |