MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for TRIFURCATED TRUWAVE CABLE 896083L3B manufactured by Edwards Lifesciences.
[126535905]
The suspect cable is sold in the eu only; therefore, no existing 510k information is applicable. This report is being communicated because a similar cable is sold and marketed in the u. S. Under model #896083021. The u. S. Cable is not sold in the eu. The cable is expected to be returned for analysis; however, at the time of this report it has not yet been received. Upon return and evaluation, a supplemental report will be sent to communicate the results of our investigation as well as our review of the device history record.
Patient Sequence No: 1, Text Type: N, H10
[126535906]
It was reported that the blue wire of a trifurcated truwave cable produced measurements which were deemed? Wrong.? The suspect? Wrong? Values were not specified. There was no allegation of patient involvement or compromise. Although requested, no further details will be forthcoming, as an additional request to the customer revealed that the device was left on a desk located in the technical department with no other information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04411 |
| MDR Report Key | 8010879 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-11-26 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2018-10-26 |
| 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 | MS. SAMANTHA EVELEIGH |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRIFURCATED TRUWAVE CABLE |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2018-10-26 |
| Returned To Mfg | 2018-11-22 |
| Model Number | 896083L3B |
| Device Expiration Date | 2018-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-26 |