MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for HUDSON RCI MEDIUM-CONCENTRATION OXYGEN MASKS, ELONGATED 1041 manufactured by Teleflex Medical.
[119660899]
Apparently, the oxygen connecting tube will not stay on the stem of the oxygen mask. It is too loose. Results in patient not getting oxygen when the tubing slips off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7859527 |
| MDR Report Key | 7859527 |
| Date Received | 2018-09-10 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-08-21 |
| Report Date | 2018-08-23 |
| Date Reported to FDA | 2018-08-23 |
| Date Reported to Mfgr | 2018-09-10 |
| Date Added to Maude | 2018-09-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HUDSON RCI MEDIUM-CONCENTRATION OXYGEN MASKS, ELONGATED |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2018-09-10 |
| Model Number | 1041 |
| Lot Number | 74F1801788 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-10 |