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 2017-02-13 for SEDLINE MONITOR 16505 manufactured by Masimo - 40 Parker.
[67249784]
The returned device was evaluated. During inspection, the unit was found to have a cracked housing. The device was able to power on and obtain valid readings with a sedline tester; however the readings could not be seen as the display was dim. The backlight inverter was found to be defective. The display was temporarily replaced with a known good display and the values verified as correct. The backlight inverter was replaced and the unit functioned as designed.
Patient Sequence No: 1, Text Type: N, H10
[67249885]
The customer reported the device will not stay powered on. No consequences or impact to patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2017-00194 |
| MDR Report Key | 6325664 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-13 |
| Date of Event | 2017-01-22 |
| Date Mfgr Received | 2017-01-22 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2017-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHARLENE JOHNSON |
| 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 MONITOR |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2017-02-13 |
| Returned To Mfg | 2017-01-27 |
| Model Number | 16505 |
| Catalog Number | 16505 |
| 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 | 2017-02-13 |