MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-28 for SUPERDIMENSION AAS00161-20 manufactured by Covidien Lp - Superdimension Inc.
[176661192]
(b)(4). Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.
Patient Sequence No: 1, Text Type: N, H10
[176661193]
According to the reporter during a procedure, the customer called to indicate that there is beeping come from the system. Blue light and green light are on indicating power but unsure where sound is coming from. The monitor also shows an amber light but no image. After restarting system, monitor came on and showed login window and no beeping. Moments later the system turned off. Upon restarting, the beeping started again. Manually powered off the ipc and the beeping stopped indicating an ipc failure. The patient is under general anesthesia. The superd portion of the case was not completed nor was it completed by other means.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2020-00006 |
| MDR Report Key | 9638405 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-28 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-01-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERDIMENSION |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-01-28 |
| Model Number | AAS00161-20 |
| Catalog Number | AAS00161-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-28 |