MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-13 for ECG SLAVE CABLE 64EKH manufactured by Edwards Lifesciences.
[188742807]
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results as well as the device history record. 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.
Patient Sequence No: 1, Text Type: N, H10
[188742808]
As reported, during use of this 64 ekh slave cable, the hemosphere monitor provided double heart rate value than the heart rate provided by the philips bedside monitor. The value provided by the bedside monitor was 70 beats/min approximately, while the hemosphere monitor displayed roughly twice the value (hr around 140 beats/min). There was no error message displayed. The issue was sometimes solved by disconnecting the power cable from the socket and letting the monitor work in battery mode. In other cases, the swan ganz was just disconnected. As per new information received from the user, the problem was found to be related to the 64 ekh slave cable, which had high resistance. The cable was replaced and the problem was solved. This issue has happened in the past as well. The hemosphere monitor functioned as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10509 |
| MDR Report Key | 9709162 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-13 |
| 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 | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| 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 | ECG SLAVE CABLE |
| Generic Name | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| Product Code | DXG |
| Date Received | 2020-02-13 |
| Model Number | 64EKH |
| Catalog Number | 64EKH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-13 |