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.
[2524959]
As the paramedics were placing the boussignac cpap system on a pt, the tubing and connection port broke off. The device was placed on correctly and there was no trauma or damage to the device noted prior to this failure. Dates of use: (b)(6) 2012 - (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024436 |
| MDR Report Key | 2474321 |
| Date Received | 2012-02-24 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-01-23 |
| 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 | BOUSSIGNAC CPAP SYSTEM |
| Product Code | BYE |
| Date Received | 2012-02-24 |
| Returned To Mfg | 2012-02-05 |
| Model Number | 5562.513 |
| Lot Number | 11H37 |
| Device Expiration Date | 2016-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |