MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-10 for CC NEXFIN WRIST UNIT A1WU28 manufactured by Edwards Lifesciences Bmeye.
[40427673]
The device is expected to be returned for evaluation. A follow-up submission will communicate the results of the device history record review, the returned product evaluation result(s), investigation, and conclusion.
Patient Sequence No: 1, Text Type: N, H10
[40427674]
It was reported that during use, the nexfin single cuff wrist unit provided 'unreliable measurements. ' further details regarding the values or meaning of 'unreliable measurements' were unable to be obtained. 'the finger cuff sometimes inflated and occasionally did not. ' additionally, halfway through a measurement, it occasionally stopped working. There was no allegation of patient compromise and no additional system-related devices were identified as suspect.
Patient Sequence No: 1, Text Type: D, B5
[46184191]
The device was manufactured december 09, 2010 and review of the device history record supports that there were no non-conformances noted during the manufacturing of the referenced device. Additionally, no prior service has been documented for this device. The actual values, reported as? Unreliable,? Were requested; however, the information was unable to be ascertained. Examination of the returned device found no fault was found. No physical damage was found in the visual inspection. It is unknown whether procedural processes or a specific circumstance played a role in the customer's experience, as the fault could not be replicated and no other issues were detected. Edwards will continue to review and monitor all events. If action is required an appropriate investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2016-00743 |
| MDR Report Key | 5492430 |
| Date Received | 2016-03-10 |
| Date of Report | 2016-02-11 |
| Date of Event | 2016-01-12 |
| Date Mfgr Received | 2016-05-18 |
| Device Manufacturer Date | 2010-12-09 |
| Date Added to Maude | 2016-03-10 |
| 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 | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES BMEYE |
| Manufacturer Street | HOOGOORDDEEF 60 |
| Manufacturer City | 1101 BE AMSTERDAM |
| Manufacturer Country | NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CC NEXFIN WRIST UNIT |
| Generic Name | PLETHYSMOGRAPH, IMPEDANCE |
| Product Code | DSB |
| Date Received | 2016-03-10 |
| Returned To Mfg | 2016-05-18 |
| Model Number | A1WU28 |
| Lot Number | 4932761 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES BMEYE |
| Manufacturer Address | HOOGOORDDEEF 60 1101 BE AMSTERDAM NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-10 |