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 2017-05-03 for SEDLINE 25761 9513 manufactured by Masimo - 40 Parker.
[74315248]
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
[74315249]
It was reported that "the customer is complaining about intermittent failure: eeg traces visible on the screen, but no psi calculation, despite clear waveforms, good quality contact (green electrodes indicator) and no emg or artf. The issue can occur from the beginning of the monitoring period or in the middle of a surgery". No known impact or consequence to patient was reported.
Patient Sequence No: 1, Text Type: D, B5
[101411084]
The returned device was evaluated, both manual and preset simulation tests passed. The device is functioning as designed. No product performance issue identified related to spo2 and pulse rate, based on the investigation above, the customer complaint could not be confirmed. A service history record review reveals that this unit was in the field for over five (5) months with no previous reported issues prior to this reported event, corrected data: (report sources) updated from? Health professional" to? Foreign, health professional, user facility"
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031172-2017-00531 |
| MDR Report Key | 6540942 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-03 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-06-02 |
| Device Manufacturer Date | 2016-12-07 |
| Date Added to Maude | 2017-05-03 |
| 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 | 2017-05-03 |
| Returned To Mfg | 2017-04-24 |
| Model Number | 25761 |
| 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 | 2017-05-03 |