MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2016-05-24 for NELLCOR, INC. D-YS manufactured by Covidien.
[45856834]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45856835]
The customer reported low readings (oximetry) with the sensors in general. There was no single patient event reported. The sensors were remove from patients and replaced. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[50830623]
(b)(4). The fault reported by the customer? Low readings? Could not be duplicated/confirmed in our laboratory, the sample returned passed all functional tests required for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2016-00446 |
| MDR Report Key | 5677375 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-12 |
| Date Mfgr Received | 2016-07-25 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2016-05-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| 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 | NELLCOR, INC. |
| Generic Name | DURA-Y SENSOR |
| Product Code | DPZ |
| Date Received | 2016-05-24 |
| Model Number | D-YS |
| Catalog Number | D-YS |
| Lot Number | 153520030XH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2016-05-24 |