MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-02 for CHEMTRON ARTICULATING ARM manufactured by American Sterilizer Co..
[22809]
Arms in operating rooms have problems with dynamic pressure and flows.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009420 |
| MDR Report Key | 33883 |
| Date Received | 1996-07-02 |
| Date Added to Maude | 1996-07-08 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHEMTRON ARTICULATING ARM |
| Generic Name | MEDICAL GAS YOKE ASSEMBLY |
| Product Code | CAM |
| Date Received | 1996-07-02 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35223 |
| Manufacturer | AMERICAN STERILIZER CO. |
| Manufacturer Address | 2424 W 23RD ST ERIE PA 16514 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-07-02 |