MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-17 for LEVELERT II FLUID LEVEL SENSOR 7211011 manufactured by Smith & Nephew, Inc..
[65354083]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[65354084]
It was reported the levelert ii fluid level sensor doesn't alarm when the fluid bag is at the desired alarm level. No backup device available. Procedure completed without a fluid management device. No patient injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[67568655]
Complaint of alarm malfunction could not be confirmed. The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process. Product passed functional testing and alarm function performed as expected. No containment or corrective actions are recommended at this time. No problem found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2017-00038 |
| MDR Report Key | 6255700 |
| Date Received | 2017-01-17 |
| Date of Report | 2017-01-02 |
| Date of Event | 2016-12-07 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2015-10-09 |
| Date Added to Maude | 2017-01-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 W. WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVELERT II FLUID LEVEL SENSOR |
| Generic Name | MONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS |
| Product Code | FLN |
| Date Received | 2017-01-17 |
| Catalog Number | 7211011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-17 |