MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-20 for DURA-Y SENSOR D-YS manufactured by Covidien.
[16186658]
Covidien received a report that the sensor reading was lower than what the patient's vitals acuratelly were. Caller stated there was no patient harm in association with this device.
Patient Sequence No: 1, Text Type: D, B5
[16442075]
(b)(4). Customer was provided assistance to troubleshoot failure and everything is reading as expected. Per information provided in the oximax dura-y directions for use in regards to possible causes for inaccurate readings: warnings: 1) failure to apply the dura-y sensor properly may cause incorrect measurements. 3) 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. 7) excessive motion may compromise performance. In such cases, try to keep the patient still or change the sensor site to one with less motion. 8) when the sensor is wrapped too tightly or supplemental tape is applied, venous pulsations may lead to inaccurate saturation measurements. Per pedicheck d-yspd pediatric spot-check clip directions for use: warnings: 2) failure to apply the pedicheck spot-check clip properly may cause incorrect measurements. 3) use of the pedicheck clip without the elastic sleeves in place may result in improper placement which can cause inaccurate measurements. 8) do not alter or modify the pedicheck clip or its components. Alterations or modifications may affect performance or accuracy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2015-00159 |
| MDR Report Key | 4533038 |
| Report Source | 06 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-01-26 |
| Date of Event | 2015-01-21 |
| Date Mfgr Received | 2015-01-26 |
| Device Manufacturer Date | 2014-03-28 |
| Date Added to Maude | 2015-03-25 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE BRAXTON |
| Manufacturer Street | 6135 GUNBARREL AVE |
| Manufacturer City | BOULDER 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 | 2015-02-20 |
| Model Number | D-YS |
| Catalog Number | D-YS |
| Lot Number | 140870181XH |
| 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 | 2015-02-20 |