MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-28 for OXIMAX N-595 PULSE OXIMETER manufactured by Covidien.
[19021861]
Received a report ths the n595 had no audio, no post (power on self-test) tone was heard when unit was turned on. Customer stated that he was able to isolate the failure to the main pcb of the unit. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
[19133780]
(b)(4). No product was returned to covidien for evaluation. Customer stated that the monitor will be removed from hospital use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00210 |
| MDR Report Key | 3817474 |
| Report Source | 06 |
| Date Received | 2014-03-28 |
| Date of Report | 2014-03-03 |
| Date of Event | 2014-03-01 |
| Date Mfgr Received | 2014-03-03 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2014-06-04 |
| 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 | COVIDIEN |
| Manufacturer Street | MICHAEL COLLINS ROAD NEW MERVE INDUSTRIAL PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| 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 | 2014-03-28 |
| Model Number | N-595 |
| Catalog Number | N-595 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | NEW MERVUE INDUSTRIAL GALWAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-28 |