MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2014-03-27 for OXIMAX N-560 PULSE OXIMETER N560 manufactured by Mediana.
[15181862]
Received a customer report of an n-560 where there was sometimes no display. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[15790374]
(b)(4). The reported complaint was verified for missing segments. Both sides of the display (front) pcb were affected. Investigation found that the 44 pin cable was disconnected from the main pcb. Re-connection of this cable allowed the unit to pass all tests.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00296 |
| MDR Report Key | 3815357 |
| Report Source | 00,01,06 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-03-05 |
| Date of Event | 2014-03-01 |
| Date Mfgr Received | 2014-03-05 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-06-16 |
| 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 MEDICAL INDUSTRY PARK DONGHWA-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 | 2014-03-27 |
| Returned To Mfg | 2014-03-05 |
| 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, MUNMAK-EUP GAGWON KS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-27 |