MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-29 for NELLCOR DS100A manufactured by Covidien.
[61267051]
Covidien/medtronic reference number (b)(4). Patient information (id, weight) as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[61267052]
The customer reported the patient was warm and peripherally well perfused and the ds100a was reading an sp02 of 100%. The abg (arterial blood gas) result at the same time on the same patient, indicated a sao2 of 80%. They removed and replaced the ds100a with a maxai sp02 sensor and the readings were was more accurate. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2016-00986 |
| MDR Report Key | 6132938 |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-04 |
| Date Mfgr Received | 2016-11-04 |
| Date Added to Maude | 2016-11-29 |
| 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 | RAY MAROOFIAN |
| Manufacturer Street | 2101 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7606035334 |
| 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 | DURASENSOR ADT DIGIT X1 |
| Product Code | DPZ |
| Date Received | 2016-11-29 |
| Model Number | DS100A |
| Catalog Number | DS100A |
| 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 | 2016-11-29 |