MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-02-11 for EDWARDS OPTICAL MODULE II OM2E manufactured by Edwards Lifesciences.
[15808880]
It was reported that the om2e displayed output values were "abnormal" and surmised to be too high with regard to the patient's clinical status. The specific details regarding the values were unable to be obtained. The cable was exchanged and the values displayed on the monitor were deemed "correct;" therefore, the clinician(s) concluded that the most probable root cause of the suspect svo2 values was attributable to the om2e cable. There was no report of patient compromise or inappropriate treatment resulting from the event. While additional information was requested, no further details were provided. No additional system-related devices were identified as suspect.
Patient Sequence No: 1, Text Type: D, B5
[15880043]
The cable was manufactured 17-dec-2012 and review of the device history record supports that there were no non-conformances noted for any reason. Examination of the returned cable was unable to detect any failure of the cable to perform as intended. The optical module passed all testing over a 24-hour testing period with no failures or issues noted for any reason. No values changed, nor were any unexpected fault messages observed on the monitor, even when the cable was manipulated to ensure that no intermittent wires were present. 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 there was no evidence of any other failure. The root cause was unable to be determined as no defect was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2014-00309 |
| MDR Report Key | 3623313 |
| Report Source | 01,05,06 |
| Date Received | 2014-02-11 |
| Date of Report | 2014-01-15 |
| Date of Event | 2014-01-14 |
| Date Mfgr Received | 2014-01-15 |
| Device Manufacturer Date | 2012-12-17 |
| Date Added to Maude | 2014-05-05 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | EDWARDS OPTICAL MODULE II |
| Generic Name | OPTICAL MODULE/OXIMETRY CABLE |
| Product Code | ISN |
| Date Received | 2014-02-11 |
| Returned To Mfg | 2014-02-05 |
| Model Number | OM2E |
| Device Expiration Date | 2016-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-11 |