MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-27 for OXIMAX DS100A DURASENSOR DS100A-1 manufactured by Covidien.
[4447327]
Caller (biomed) stated that sensor was returned to the biomed within the last two months. It had been reported that this ds100a sensor was giving low readings while monitoring a patient. It was not reported what the actual reading value wa nor was it reported if it was pulse rate or spo2 rate that were low. Caller stated that no further information was available. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[11731482]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00294 |
| MDR Report Key | 3815355 |
| Report Source | 06 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-02-28 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-02-28 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2014-06-16 |
| 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 | BLVD. INSURGENTES PARCELA #37 |
| Manufacturer City | TIJUANA, BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIMAX DS100A DURASENSOR |
| Generic Name | ADULT OXYGEN SENSOR |
| Product Code | DPZ |
| Date Received | 2014-03-27 |
| Catalog Number | DS100A-1 |
| Lot Number | 2048069X |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | BLVD. INSURGENTES PARCEL TIJUANA, BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-27 |