MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-08 for MAXBLEND R204P05-001 * manufactured by Maxtec, Llc.
[4660648]
Blender delivered 21% with dial set at 100% fio2. Incident occurred during infant delivery/resuscitation. There was no injury to the patient. Saturation improved after oxygen was delivered. ====================== manufacturer response for air/o2 blender, maxblend high-flow (per site reporter). ====================== maxtec will obtain product complaint that has been filed and has obtained unit for testing. Maxtec will also involve carefusion as the actual manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3840273 |
| MDR Report Key | 3840273 |
| Date Received | 2014-04-08 |
| Date of Report | 2014-04-08 |
| Date of Event | 2014-04-02 |
| Report Date | 2014-04-08 |
| Date Reported to FDA | 2014-04-08 |
| Date Reported to Mfgr | 2014-05-30 |
| Date Added to Maude | 2014-05-30 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXBLEND |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | CCL |
| Date Received | 2014-04-08 |
| Returned To Mfg | 2014-04-08 |
| Model Number | R204P05-001 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXTEC, LLC |
| Manufacturer Address | 6526 SOUTH COTTONWOOD STREET 300 WEST SALT LAKE CITY UT 84107 US 84107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-08 |