MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for CC CABLES 70CC2 manufactured by Edwards Lifesciences.
[100040713]
Examination of the returned device was able to confirm the reported customer complaint. During evaluation, a fault message? Blood temp out of range ( <31*c or >41* c )? Was observed. This is thought to be due to customer abuse. The cable will need to be scrapped. A follow-up submissions will be sent to communicate the results of the device history records review and engineering evaluation results. It should be noted that the product evaluation of the monitor involved in this complaint showed no defect found. The patient? S body temperature by can be obtained by different means and compared to the temperature obtained from the catheter. If they do not correlate to the clinician? S satisfaction, it is common clinical practice to begin the troubleshooting process to discover the suspect device. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review. No corrective or preventative actions are required at this time.
Patient Sequence No: 1, Text Type: N, H10
[100040714]
It was reported that during use of the vig2 monitor, when the axillary temperature of the patient was 36? C, the blood temperature displayed on the vig2 was 38? C. After the suspect vig2 monitor and cables were replaced, the bt displayed was 36? C. At the time when the incorrect bt occurred, cco was also being measured along with the axillary temperature. No error message displayed was confirmed. There was no problems involved with any clinical treatment to patient. Patient demographics were unavailable at this time. There was no report of any patient compromise or injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-00443 |
| MDR Report Key | 7259794 |
| Date Received | 2018-02-09 |
| Date of Report | 2018-01-18 |
| Date of Event | 2018-01-18 |
| Date Mfgr Received | 2018-04-02 |
| Device Manufacturer Date | 2015-07-20 |
| Date Added to Maude | 2018-02-09 |
| 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 | MS. LYNN SELAWSKI |
| Manufacturer Street | ONE 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 | 0 |
| Brand Name | CC CABLES 70CC2 |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2018-02-09 |
| Returned To Mfg | 2018-02-04 |
| Model Number | 70CC2 |
| Device Expiration Date | 2018-12-15 |
| 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 | 2018-02-09 |