MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-12 for SEDATION SYSTEMS LLC CA 0120MX manufactured by Sedations Systems And Sedation.
[18527600]
Based on a headache complaint, some nitrous oxide field screening was done on the sedation systems disposable sedation-breathing circuit and mask set. The areas identified were the assembled plastic distribution tubes. This appears to be a mfg defect in the tube materials and seemed to worsen when the tube was bent or stressed. The nitrous levels were elevated significantly above the standard for the following lots lot #981383 and lot # 89364. We suspended services, removed the product, and contacted the mfr. We requested and received qa/qc pressure test data on lot # 981383. This was a one page report that indicates a? P? For air pressure, pull test, and visual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027326 |
| MDR Report Key | 2804116 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-12 |
| Date Added to Maude | 2012-10-26 |
| 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 | RISK MANAGER |
| 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 | SEDATION SYSTEMS LLC |
| Generic Name | DISPOSABLE SEDATION-BREATHING CIRCUIT AND MASK SET |
| Product Code | BSJ |
| Date Received | 2012-10-12 |
| Returned To Mfg | 2012-10-11 |
| Catalog Number | CA 0120MX |
| Lot Number | 89364 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEDATIONS SYSTEMS AND SEDATION |
| Manufacturer Address | CLEARWATER FL 33759 US 33759 |
| Brand Name | SEDATION SYSTEMS LLC |
| Generic Name | DISPOSABLE SEDATION-BREATHING CIRCUIT AND MASK SET |
| Product Code | BSJ |
| Date Received | 2012-10-12 |
| Returned To Mfg | 2012-10-11 |
| Catalog Number | CA 0120MX |
| Lot Number | 981383 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SEDATIONS SYSTEMS AND SEDATION |
| Manufacturer Address | CLEARWATER FL 33759 US 33759 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-12 |