MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for OXYMASK O2KID manufactured by Southmedic.
[143044648]
Pediatric oxymask noted to be ver loud with oxygen administration and the pt required increased oxygen. Upon exam of the oxymask, a kink in the tubing was noted at the base of mask that twisted and blocked the oxygen administration to the pt. Different mask was placed on the pt and the problem resolved. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086084 |
| MDR Report Key | 8544756 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-21 |
| Date Added to Maude | 2019-04-24 |
| 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 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 | 0 |
| Brand Name | OXYMASK O2KID |
| Generic Name | MASK OXYGEN |
| Product Code | BYG |
| Date Received | 2019-04-23 |
| Lot Number | LO1936F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTHMEDIC |
| Manufacturer Address | BARRIE,ON CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |