MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-10 for OXIMAX N-595 PULSE OXIMETER N595-1 manufactured by Mediana Co. Ltd..
[179271246]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179271247]
According to the reporter, the unit's alarm sounds powered on but does not work properly. It was stated that alarm never works. There was no allegation of patient death or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00045 |
| MDR Report Key | 9578618 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-10 |
| Date of Report | 2020-02-27 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2005-05-17 |
| Date Added to Maude | 2020-01-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MEDIANA CO. LTD. |
| Manufacturer Street | 1650 1 2 DONGHWA RI MUNMAK EU |
| Manufacturer City | KANGWON DO WONJU SI 00000 |
| Manufacturer Country | KR |
| Manufacturer Postal Code | 00000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIMAX N-595 PULSE OXIMETER |
| Product Code | PGJ |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2019-12-23 |
| Model Number | N595-1 |
| Catalog Number | N595-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIANA CO. LTD. |
| Manufacturer Address | 1650 1 2 DONGHWA RI MUNMAK EU KANGWON DO WONJU SI 00000 KR 00000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |