MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-21 for NELLCOR D-YS manufactured by Covidien.
[44040737]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44040738]
The user was expecting normal readings (high 90s or 100 %). The sensor had been in use 10 minutes. The spo2 reading ended up being low at 74 %. They determined that this is low based on the condition of the patient. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2016-00301 |
| MDR Report Key | 5595371 |
| Date Received | 2016-04-21 |
| Date of Report | 2016-03-28 |
| Date Mfgr Received | 2016-03-28 |
| Device Manufacturer Date | 2011-06-23 |
| Date Added to Maude | 2016-04-21 |
| 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 | MEDICAL ASSISTANT |
| 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 | 0 |
| Brand Name | NELLCOR |
| Generic Name | DURA-Y SENSOR |
| Product Code | DPZ |
| Date Received | 2016-04-21 |
| Model Number | D-YS |
| Catalog Number | D-YS |
| Lot Number | 1175069X |
| 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 | 2016-04-21 |