MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-04-15 for OXIMAX N-560 PULSE OXIMETER N560 manufactured by Mediana.
[4539269]
A n-560 was returned to a covidien service center with a report of a display error. On (b)(6) 2014, upon investigation, covidien determined that the display was intermittently missing segments. There was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
[12021718]
(b)(4). Covidien verified an intermittent failure of the front pcb and main pcb boards, these pcb boards were replaced and the unit passed tests.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00344 |
| MDR Report Key | 3888086 |
| Report Source | 01,06,07 |
| Date Received | 2014-04-15 |
| Date of Report | 2014-04-02 |
| Date of Event | 2014-03-20 |
| Date Mfgr Received | 2014-04-02 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2014-07-07 |
| 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 | SONJU MEDICAL INDUSTRY PARK DONGHWA-RI, MUNMAK-EUP, WONJU-SI |
| Manufacturer City | GANGWON-DO |
| Manufacturer Country | KN |
| 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 | 2014-04-15 |
| Returned To Mfg | 2014-03-31 |
| Model Number | N-560 |
| Catalog Number | N560 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIANA |
| Manufacturer Address | WONJU INDUSTRY PARK DONGHWA-RI, MUNMAKE GONGWON KN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-15 |