MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for SALTER LAB 8150 PERCENT - O2 - LOCK MASK manufactured by Salter Labs.
[99930390]
Snf reported to oncall rt that when they connect sal 8150 venti mask sett at 35 percent/ 6 lpmflow on 10 lpn melloniumconcentrator drop from set 6 to 4 lpm. Rt had them try 12 different concentrators and multiple 81505, 3 in total with no end. Resident switched to different venturi mask device from different manufacturer that didn't cause in liter flow and delivered prescribed fio2 percent. Dose or amount: o2 @ 6 lpm, frequency: continuous, route: ventitimask. Dates of use: (b)(6) 2018. Diagnosis or reason for use: copd.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075180 |
| MDR Report Key | 7263321 |
| Date Received | 2018-02-09 |
| Date of Report | 2018-01-30 |
| Date of Event | 2018-01-10 |
| Date Added to Maude | 2018-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER CAREGIVERS |
| 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 | 0 |
| Brand Name | SALTER LAB 8150 PERCENT - O2 - LOCK MASK |
| Generic Name | VENTIMASK |
| Product Code | KGB |
| Date Received | 2018-02-09 |
| Model Number | 8150 |
| Lot Number | (10)011915 (10)N0P070317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SALTER LABS |
| Manufacturer Address | 100 WEST SYCAMORE RD. ARVIN CA 93203 US 93203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-09 |