MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-31 for ANESTHESIA-RX? ANESTHESIA-RX 7.1.2 manufactured by Aesynt Incorporated.
[54326067]
The device was taken out of service and returned to the manufacturer for evaluation. A definitive root cause cannot be identified at this time, however enhancements to anesthesia-rx? Implemented in 2013 are believed to mitigate the occurrence of this type of event on devices manufactured after that time. The subject device was manufactured prior to the 2013 enhancements. Upon its return to the manufacturer for evaluation, a new product was provided to the reporting site.
Patient Sequence No: 1, Text Type: N, H10
[54326068]
On (b)(6) 2016, a report was received from a customer stating that while using an aesynt incorporated anesthesia-rx medication dispensing cart, they began to notice smoke and a smell of burning while performing a surgery. The device was promptly removed from the room and neither the patient nor staff was injured in this incident. Reference inquiry number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011278888-2016-00001 |
| MDR Report Key | 5919939 |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-03 |
| Date Mfgr Received | 2016-08-03 |
| Device Manufacturer Date | 2011-08-30 |
| Date Added to Maude | 2016-08-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LORI JASHINSKI |
| Manufacturer Street | 500 CRANBERRY WOODS DRIVE SUITE 400 |
| Manufacturer City | CRANBERRY TOWNSHIP PA 16066 |
| Manufacturer Country | US |
| Manufacturer Postal | 16066 |
| Manufacturer Phone | 4129012531 |
| Manufacturer G1 | AESYNT INCORPORATED |
| Manufacturer Street | 51 PENNWOOD PLACE SUITE 400 |
| Manufacturer City | WARRENDALE PA 15086 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15086 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANESTHESIA-RX? |
| Generic Name | ANESTHESIA CART |
| Product Code | BRY |
| Date Received | 2016-08-31 |
| Returned To Mfg | 2016-08-04 |
| Model Number | ANESTHESIA-RX 7.1.2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT INCORPORATED |
| Manufacturer Address | 51 PENNWOOD PLACE SUITE 400 WARRENDALE PA 15086 US 15086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-31 |