MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-24 for OXIMAX N-560 PULSE OXIMETER N560 manufactured by Mediana.
[5007600]
Covidien recieved a report of a n560 where the far left segment on the display was intermitently not displayed. This location is on the saturation readings portion of the device. No patient harm was reported to covidien.
Patient Sequence No: 1, Text Type: D, B5
[12574685]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00970 |
| MDR Report Key | 4274839 |
| Report Source | 05,06 |
| Date Received | 2014-11-24 |
| Date of Report | 2014-10-27 |
| Date of Event | 2014-10-27 |
| Date Mfgr Received | 2014-10-27 |
| Device Manufacturer Date | 2011-08-23 |
| Date Added to Maude | 2014-12-03 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE BRAXTON |
| Manufacturer Street | 6135 GUNBARREL AVE. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3038768909 |
| Manufacturer G1 | MEDIANA |
| Manufacturer Street | DONGWHA-RI MANMUK-EUP,WONJU-SI |
| Manufacturer City | GANGWON-DO 220-801 |
| Manufacturer Country | KS |
| Manufacturer Postal Code | 220-801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIMAX N-560 PULSE OXIMETER |
| Generic Name | PULSE OXIMETER |
| Product Code | DPZ |
| Date Received | 2014-11-24 |
| Returned To Mfg | 2014-11-04 |
| Model Number | N-560 |
| Catalog Number | N560 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIANA |
| Manufacturer Address | WONJU MEDICAL INDUSTRY PARK DONGWHA-RI, MUNMAK-EUP WONJU-SI, GANGWON-DO 220-801 KS 220-801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-24 |