MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-04-02 for FLOTRAC CONNECTING CABLE EVFTCL manufactured by Edwards Lifesciences.
[4308229]
It was reported that the mean arterial pressure (map) was inaccurately displayed on the ev1000 monitor. When map displayed as 80mmhg on the patient monitor, it displayed as 40mmhg on the ev1000 monitor. The customer surmised that the value on ev1000 was demonstrably wrong, therefore they exchanged the ev1000 system for a vigileo monitor immediately, and the issue was resolved. Two complaints were initiated; one (1) for the ev1000 monitor and one (1) for the system related component: the flotrac cable. There was no report of patient compromise or inappropriate treatment resulting from the reported event.
Patient Sequence No: 1, Text Type: D, B5
[11723032]
A device evaluation is anticipated but was not complete at the time of this report. The evaluation results, investigation, and a conclusion will be communicated in a follow-up submission. An additional mdr was submitted for the system-related ev1000 monitor (reference mdr number 2015691-2014-00764).
Patient Sequence No: 1, Text Type: N, H10
[12113568]
The customer? S complaint was unable to be replicated during examination of the returned device, as the cable performed as expected with no failures noted for any reason. Conductivity testing was performed with passing results and no physical damage was observed during the visual inspection. Therefore, the flotrac connecting cable can reasonably be exempted as a contributor to the customer? S complaint. A system-related ev1000 monitor malfunction was identified as the root cause of the customer? S experience (reference mdr 2015691-2014-00764). The flotrac cable will be returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2014-00767 |
| MDR Report Key | 3723046 |
| Report Source | 01,06 |
| Date Received | 2014-04-02 |
| Date of Report | 2014-03-04 |
| Date of Event | 2014-03-04 |
| Date Mfgr Received | 2014-05-27 |
| Device Manufacturer Date | 2012-04-03 |
| Date Added to Maude | 2014-04-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. LYNN SELAWSKI |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOTRAC CONNECTING CABLE |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2014-04-02 |
| Model Number | EVFTCL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-04-02 |