MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,06 report with the FDA on 2013-07-19 for FLOTRAC CONNECTION CABLE 9 FT APCO9 manufactured by Edwards Lifesciences.
[3601553]
It was reported that on three (3) occasions the customer surmised that the vigileo monitor was not providing values which were representative of the patient? S clinical condition. During all of the referenced events, the same type of patient was involved? An elderly patient in a compromised condition. The actual values observed were not provided; however, the values were suggestive of a young and fit person, and therefore questionable. The customer reasoned that the issue originated with the monitor and was not the result of any failure related to the flotrac, as the incidents occurred with three (3) patients utilizing three (3) different flotrac sensors; the shared (common denominator) device involved with all of the events was the vigileo monitor. Three (3) devices were reported, although only two (2) were identified as potentially related to this event. The additional system components are the referenced apco9 cable and a px1800 connecting cable (bedside cable). The bedside cable was not implicated as a potential contributor in the event and was supplied by the sales representative as a matter of course. Edwards does not hold reporting responsibilities for the bedside cable and the manufacturer was notified. No patient compromise was reported.
Patient Sequence No: 1, Text Type: D, B5
[10945500]
The apco9 cable was manufactured 08-05-2009 and review of the device history record supports that there were no non-conformances for any reason. Mfr report # 2015691-2013-20648 was filed for the vigileo monitor. Examination of the returned vigileo monitor and accessories was unable to detect any failure of any device to function as intended. Examination of the subject device for this report (apco9 cable) was also unable to detect any failure of the cable to perform as intended. The cable was evaluated in accordance with the provisions of the standard operating procedure and no defect was found. It is unknown whether procedural processes or a specific circumstance played a role in the reported experience, as no fault could be identified and the evaluation results did not confirm the reported issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2013-20649 |
| MDR Report Key | 3238414 |
| Report Source | 01,04,05,06 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-06-21 |
| Date of Event | 2013-06-18 |
| Date Mfgr Received | 2013-06-21 |
| Device Manufacturer Date | 2009-08-05 |
| Date Added to Maude | 2013-07-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID VU |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502435 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOTRAC CONNECTION CABLE 9 FT |
| Generic Name | CONNECTING CABLE |
| Product Code | ISN |
| Date Received | 2013-07-19 |
| Model Number | APCO9 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| 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 | 2013-07-19 |