MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-04-08 for OXIMAX N-560 PULSE OXIMETER N560 manufactured by Mediana.
[4462031]
It was reported to covidien that the unit's display is not lighting up all the way. Covidien investigation verified the unit display was missing segments. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
[12089037]
The issue was isolated to the display pcb. The display pcb was replaced. (b)(4). The serial number of the display pcb precedes a corrective and preventive action taken by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00329 |
| MDR Report Key | 3880248 |
| Report Source | 06,07 |
| Date Received | 2014-04-08 |
| Date of Report | 2014-03-18 |
| Date of Event | 2014-03-01 |
| Date Mfgr Received | 2014-03-18 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-07-02 |
| 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 | 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 | WONJU INDUSTRY PARK DONGWHA-RI, MUNMAK-EUP, WONJU-SI |
| Manufacturer City | GANGWON-DO |
| Manufacturer Country | KS |
| 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 | 2014-04-08 |
| Returned To Mfg | 2014-03-19 |
| Model Number | N-560 |
| Catalog Number | N560 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIANA |
| Manufacturer Address | WONJU INDUSTRY PARK DONGWHA-RI, MUNMAK-EUP GANGWON KS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-08 |