MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for NASAL ALAR SP02 SENSOR 301-11214 manufactured by Xhale Assurance, Inc..
[180170746]
Skin breakdown (burn vs. Pressure-related breakdown) noted at patient nare where pulse oximetry sensor device had been in place. Similar skin breakdown noted in a second patient in a different icu location. Both patients in critical care settings with vasopressor(s) infusion requirements. Suspect possible issue with staff not rotating the probe site as frequent as per manufacturer recommendations for patients at high risk of skin breakdown. More education is likely warranted. Recommendations from manufacturer have been (for high risk population) to rotate site every 4 hours and assess site at least every 2 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9732060 |
| MDR Report Key | 9732060 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-23 |
| Report Date | 2020-02-18 |
| Date Reported to FDA | 2020-02-18 |
| Date Reported to Mfgr | 2020-02-20 |
| Date Added to Maude | 2020-02-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASAL ALAR SP02 SENSOR |
| Generic Name | OXIMETER |
| Product Code | DQA |
| Date Received | 2020-02-20 |
| Model Number | 301-11214 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XHALE ASSURANCE, INC. |
| Manufacturer Address | 3630 SW 47TH AVE SUITE 100 GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-20 |