MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-05 for BOUSSIGNAC CPAP SYSTEM REF 5562.513 5562.513 manufactured by Vygon.
[2623381]
An (b)(6) emergency medical services team was called to a nursing home to assist a (b)(6) male. He was found to be in cute congestive heart failure; rhonchi in all lung fields, with hypoxia. Spo2 82% on 6lpm by nasal cannula was attempted to be treated with a vygon boussignac cpap system lot 11a11. When removed from packaging, the device was found to be broken at the point that the oxygen supply line contacts the delivery port and was thus unusable. An alternative cpap system was rapidly obtained and no adverse pt outcome occurred. A second vygon boussignac cpap system from the same lot was obtained to replace the faulty system and found to have the same defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024964 |
| MDR Report Key | 2532160 |
| Date Received | 2012-04-05 |
| Date of Report | 2012-04-05 |
| Date of Event | 2012-04-02 |
| Date Added to Maude | 2012-04-13 |
| 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 | BOUSSIGNAC CPAP SYSTEM |
| Generic Name | CPAP |
| Product Code | BYE |
| Date Received | 2012-04-05 |
| Model Number | REF 5562.513 |
| Catalog Number | 5562.513 |
| Lot Number | 11A11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-05 |