MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-06 for ACUDOSE-RX * manufactured by Aesynt, Incorporated.
[5127183]
Patient was hemorrhaging. Two acudose units would not open. There was a resultant delay in treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4390720 |
| MDR Report Key | 4390720 |
| Date Received | 2015-01-06 |
| Date of Report | 2015-01-06 |
| Date of Event | 2014-12-29 |
| Report Date | 2015-01-06 |
| Date Reported to FDA | 2015-01-06 |
| Date Reported to Mfgr | 2015-01-07 |
| Date Added to Maude | 2015-01-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUDOSE-RX |
| Generic Name | CABINET, TABLE AND TRAY, ANESTHESIA |
| Product Code | BRY |
| Date Received | 2015-01-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT, INCORPORATED |
| Manufacturer Address | 500 CRANBERRY WOODS DR. SUITE 400 CRANBERRY TOWNSHIP PA 16066 US 16066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-06 |