MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-23 for SEDLINE PATIENT CABLE 23858 3637 manufactured by Masimo - 52 Discovery.
[80784618]
Additional manufacturing narrative: the returned cable was evaluated and found to be functioning as designed. All electrodes displayed color green on monitor, indicating electrode impedance was within the acceptable range. No red lines across the field were observed. No product performance issue identified, based on the investigation above, the customer complaint could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
[80784619]
The customer reported the following issue: "dsa display showed red lines across the field, not having seen this pattern before, physician called me in the room to verify the information, i guided him to check lead placement, and proceeded to exchange the patient cable, at which point the problem was resolved. Picture attached. Troubleshooting steps: the patient sensor was changed, lead placement was confirmed, but, same bad results. Dsa continued to show altered. Changed patient cable, and dsa showed more in according to clinical scenario. Never changed the sedline module, but changing the sedline patient cable solved the issue. " no consequences or impact to patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2017-00734 |
| MDR Report Key | 6734965 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-23 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2016-11-04 |
| Date Added to Maude | 2017-07-23 |
| 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 | STEFAN LISSMANN |
| Manufacturer Street | 52 DISCOVERY |
| Manufacturer City | IRVINE CA 926181604 |
| Manufacturer Country | US |
| Manufacturer Postal | 926181604 |
| Manufacturer Phone | 9492977000 |
| Manufacturer G1 | INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V. |
| Manufacturer Street | CALZADA DEL ORO, NO. 2001 PARQUE INDUSTRIAL PALACO |
| Manufacturer City | MEXICALI, BAJA CALIFORNIA 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDLINE PATIENT CABLE |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2017-07-23 |
| Returned To Mfg | 2017-07-14 |
| Model Number | 23858 |
| Catalog Number | 3637 |
| Lot Number | A16M058 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO - 52 DISCOVERY |
| Manufacturer Address | 52 DISCOVERY IRVINE CA 926181604 US 926181604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-23 |