MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for NELLCOR MAXFAST manufactured by Tijuana-rx.
[63184982]
(b)(4). Patient information (id, age, sex, weight) has been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report. Medtronic is attempting to gather additional information surrounding the circumstances associated to this event.
Patient Sequence No: 1, Text Type: N, H10
[63184983]
Medtronic received a report that experienced a pressure ulcer burn from a maxf spo2 sensor. Information regarding any required intervention performed was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2016-01093 |
| MDR Report Key | 6200707 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-02 |
| Date Mfgr Received | 2016-12-02 |
| Device Manufacturer Date | 2016-09-09 |
| Date Added to Maude | 2016-12-22 |
| 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 | TIJUANA-RX |
| 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 | PATIENT TRANSDUCER AND ELECTRODE CABLE |
| Product Code | DSA |
| Date Received | 2016-12-22 |
| Model Number | MAXFAST |
| Catalog Number | MAXFAST |
| Lot Number | 162530093H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIJUANA-RX |
| Manufacturer Address | BLVD. INSURGENTES PARCELA #37 TIJUANA, BC MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-22 |