MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2014-11-05 for DURA-Y SENSOR D-YS manufactured by Covidien.
[5001075]
It was reported sensor showed of 56-60 % with a nellcor handheld monitor (model and serial number is unknown). Covidien has attempted to gather further details surrounding the circumstances of this report, without success.
Patient Sequence No: 1, Text Type: D, B5
[12443079]
(b)(4). No sample is expected to be returned. Without the actual complaint sample a full investigation cannot be completed therefore we are unable to determine the cause for this specific event. Per information provided in the oximax dura-y directions for use in regards to possible causes for inaccurate readings: warnings: failure to apply the dura-y sensor properly may cause incorrect measurements. Using the dura-y sensor in the presence of bright lights may result in inaccurate measurements. In such cases, cover the sensor with an opaque material. Excessive motion may compromise performance. In such cases, try to keep the patient still or change the sensor site to one with less motion. When the sensor is wrapped too tightly or supplemental tape is applied, venous pulsations may lead to inaccurate saturation measurements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00962 |
| MDR Report Key | 4226639 |
| Report Source | 04,06 |
| Date Received | 2014-11-05 |
| Date of Report | 2014-10-10 |
| Date Mfgr Received | 2014-10-10 |
| Device Manufacturer Date | 2012-10-30 |
| Date Added to Maude | 2014-11-18 |
| 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 GUNBARRELL 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 |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURA-Y SENSOR |
| Generic Name | D-YS |
| Product Code | DPZ |
| Date Received | 2014-11-05 |
| Model Number | D-YS |
| Catalog Number | D-YS |
| Lot Number | 122900455X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | BLVD. INSURGENTES PARCELA #37 TIJUANA, BC MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-05 |