MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-04-30 for OXIMAX N-560 PULSE OXIMETER manufactured by Mediana.
[4424387]
Received a report that the n-560 is intermittently missing segments on the saturation portion of the display. The failure happened during preventive maintenance when the device was not being used on a patient.
Patient Sequence No: 1, Text Type: D, B5
[12020216]
(b)(4). The unit passed all functional tests without an intermittent failure; however, upon visual inspection solder defects were identified on the front pcb and main pcb boards. These boards were replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00360 |
| MDR Report Key | 3888552 |
| Report Source | 01,06 |
| Date Received | 2014-04-30 |
| Date of Report | 2014-04-14 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-04-14 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2014-07-08 |
| 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-SHI |
| Manufacturer City | GANGWON-DON |
| 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 | 2014-04-30 |
| Returned To Mfg | 2014-04-16 |
| Model Number | N-560 |
| Catalog Number | N-560 |
| 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 GANGWON-DO KS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-30 |