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 2017-07-26 for SEDLINE 24295 9513 manufactured by Masimo - 40 Parker.
[81143717]
The returned module was evaluated. No artifacts or abnormal signals were observed. In addition there were no present errors or interruptions to the measurements observed. Upon an inspection bending test of the cable no loss in measurements were found. The unit was found to visually and audibly alarm during alarm conditions. The sedline module was determined to be functioning as designed.
Patient Sequence No: 1, Text Type: N, H10
[81143718]
The customer reported the dsa was displaying a horizontal pattern that was not associated with the patient. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2017-00735 |
| MDR Report Key | 6746030 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-26 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-06-30 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2017-07-26 |
| 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 | 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 | 2017-07-26 |
| Returned To Mfg | 2017-07-21 |
| Model Number | 24295 |
| Catalog Number | 9513 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-07-26 |