MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-02-23 for SEDLINE SENSOR 25761 2479 manufactured by Masimo - 40 Parker.
[68221070]
The product has been returned to masimo for evaluation. When the investigation is complete a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[68221071]
The customer reported multiple events of interruption of monitoring with sensors. Limited information regarding the number of patients involved or number of events was provided; however the customer has indicated that the issue has occurred in multiple operating theaters. No consequences or impact to patient were reported.
Patient Sequence No: 1, Text Type: D, B5
[74821821]
The returned device was evaluated. During evaluation the device passed all visual and functional testing. The unit was found to visually and audibly alarm during alarm conditions. The unit was determined to be functioning as designed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031172-2017-00243 |
| MDR Report Key | 6355381 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-23 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2016-07-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GAIL HAPNER |
| 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 SENSOR |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2017-02-23 |
| Returned To Mfg | 2017-02-20 |
| Model Number | 25761 |
| Catalog Number | 2479 |
| 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 |