MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-17 for KING MASK * 1065 manufactured by King Systems Corporation.
[16749343]
Anesthesiologist reported a defect in the seal between the inflatable rim of the mask and the plastic base resulting in an inadequate seal for ventilation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2663498 |
| MDR Report Key | 2663498 |
| Date Received | 2012-07-17 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-07-06 |
| Report Date | 2012-07-17 |
| Date Reported to FDA | 2012-07-17 |
| Date Added to Maude | 2012-07-20 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KING MASK |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2012-07-17 |
| Model Number | * |
| Catalog Number | 1065 |
| Lot Number | IZTV1 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KING SYSTEMS CORPORATION |
| Manufacturer Address | 15011 HERRIMAN BLVD. NOBLESVILLE IN 46060 US 46060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-17 |