MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-26 for OXIMAX N-595 PULSE OXIMETER N595 manufactured by Covidien.
[20019826]
It was reported to covidien by the biomedical engineer that this n-595 has no audio. The facility biomed engineer isolated the issue to the main pcb board. There was no pt involvement reported.
Patient Sequence No: 1, Text Type: D, B5
[20302650]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00562 |
| MDR Report Key | 3960782 |
| Report Source | 06 |
| Date Received | 2014-06-26 |
| Date of Report | 2014-06-03 |
| Date of Event | 2014-06-01 |
| Date Mfgr Received | 2014-06-03 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2014-08-01 |
| 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 Street | 6135 GUNBARREL AVE. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3038768909 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | NEW MERVUE INDUSTRIAL PARK MICHAEL COLLINS RD |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIMAX N-595 PULSE OXIMETER |
| Generic Name | PULSE OXIMETER |
| Product Code | DPZ |
| Date Received | 2014-06-26 |
| Model Number | N-595 |
| Catalog Number | N595 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | NEW MARVUE INDUSTRIAL PARK GALWAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-26 |