MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-05 for NELLCOR D-YS manufactured by Covidien Ag Nellcor.
[182169157]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182169158]
According to the reporter, the unit had system failure errors with both cables switched between machines despite battery changes. The unit usually had low reading ranging 90's, 90-93. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00184 |
| MDR Report Key | 9792307 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-07-27 |
| Date Added to Maude | 2020-03-05 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | COVIDIEN AG NELLCOR |
| Manufacturer Street | BOULEVARD INSURGENTES |
| Manufacturer City | TIJUANA,BC 22225 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22225 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NELLCOR |
| Generic Name | OXIMETER |
| Product Code | DQA |
| Date Received | 2020-03-05 |
| Model Number | D-YS |
| Catalog Number | D-YS |
| Lot Number | 182150039H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN AG NELLCOR |
| Manufacturer Address | BOULEVARD INSURGENTES TIJUANA,BC 22225 MX 22225 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |