MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2015-03-03 for OXIMAX N595 manufactured by Covidien.
[15245282]
It was reported that during testing of the pulse oximeter the sound delivered from the speaker sounded "weak and raspy". There was no reported patient involvement. There is no report of death or serious injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[15550115]
(b)(4). A technical support engineer (tse) assisted the distributor with troubleshooting the device via phone. Upon visual inspection of the device, the distributor found the speaker wires to be pinched. The distributor stated neither the device nor it's components will be returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2015-00185 |
| MDR Report Key | 4564983 |
| Report Source | 05,08 |
| Date Received | 2015-03-03 |
| Date of Report | 2015-02-09 |
| Date Mfgr Received | 2015-02-09 |
| Device Manufacturer Date | 2002-07-19 |
| Date Added to Maude | 2015-04-03 |
| 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 | 2015-03-03 |
| Model Number | N595 |
| Catalog Number | N595 |
| 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 PARK MICHAEL COLLINS ROAD GALWAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-03 |