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 2017-02-23 for SEDLINE 9513 manufactured by Masimo - 40 Parker.
[68132786]
Attempts have been made to obtain the product. The product has not been returned to masimo to allow an analysis to be performed. If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[68132787]
It was reported that the doctor traditionally uses the emg as a logarithmic scale on the bis. Meaning that when the emg (without the interference of diathermia) is above 30%, it is an indication of a pain noxious stimuli. Thereby, he would treat the patient with analgesia rather than sedation. However, with the sedline emg, the doctor noticed when using it on a lap chol without the use of a spinal or a block, the sedline emg remained at 0% throughout the case. Whereas the bis was indicating that the patient had noxious stimuli, which the doctor felt fitted to the clinical situation. He has seen this situation during several other cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2017-00240 |
| MDR Report Key | 6352668 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-23 |
| Date of Event | 2017-01-29 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-02-23 |
| 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 |
| Generic Name | OXIMETER |
| Product Code | GWQ |
| Date Received | 2017-02-23 |
| Returned To Mfg | 2017-03-27 |
| Model Number | 9513 |
| Catalog Number | 9513 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO - 40 PARKER |
| Manufacturer Address | 40 PARKER IRVINE CA 926181604 US 926181604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-23 |