MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-09 for OXIMAX N595 manufactured by Covidien.
[5483429]
It was reported that during an equipment check a pulse oximetry device had no audio alarms. There was no patient involvement. There was no report of serious injury or death associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[13025324]
(b)(4). The customer was made aware that this unit is at its end of life (eol). An eol letter was sent to customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2015-00148 |
| MDR Report Key | 4583258 |
| Report Source | 05,07 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-02-12 |
| Date Mfgr Received | 2015-02-12 |
| Device Manufacturer Date | 2005-05-11 |
| Date Added to Maude | 2015-04-08 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE BRAXTON |
| Manufacturer Street | 6135 GUNBARREL AVENUE |
| 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 ROAD |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIMAX |
| Generic Name | PULSE OXIMETER |
| Product Code | DPZ |
| Date Received | 2015-03-09 |
| Model Number | N595 |
| Catalog Number | N595 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | NEW MERVUE INDUSTRIAL PARK MICHAEL COLLINS ROAD GALWAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-09 |