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 2017-12-20 for UMBILICAL CABLE M004RAUMBILICAL20 RAUMBILICAL2 manufactured by Arden Hills, Mn.
[95672261]
The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95672262]
Same case as mdr: 2134265-2017-12778. It was reported that foreign matter was present. A rhythmia umbilical cable st and intellamap orion? Were selected to be used in a procedure however it was noticed that when disconnecting the catheter from the umbilical cable a the connector was wet on one part with some oily liquid. "it was not clear if this came from the catheter or from the cable. " both the umbilical cable and orion were replaced to complete the procedure. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-12777 |
| MDR Report Key | 7134090 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-20 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2018-01-18 |
| Date Added to Maude | 2017-12-20 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | ARDEN HILLS, MN |
| Manufacturer Street | 4100 HAMLINE AVENUE |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-12-20 |
| Returned To Mfg | 2018-01-03 |
| Model Number | M004RAUMBILICAL20 |
| Catalog Number | RAUMBILICAL2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARDEN HILLS, MN |
| Manufacturer Address | 4100 HAMLINE AVENUE ST. PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-20 |