MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-09 for BUBBLE GUM SCENTED AMBU KING MASK K1122 manufactured by Ambu A/s.
[123491078]
Five bubble gum scented size 2 - ambu king mask (lot 1976227) seat not inflated. Staff is having to use a syringe and inflate with air prior to use. Masks will hold the air once manually inflated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080430 |
| MDR Report Key | 7951752 |
| Date Received | 2018-10-09 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-10-04 |
| Date Added to Maude | 2018-10-10 |
| 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 |
| 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 | BUBBLE GUM SCENTED AMBU KING MASK |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2018-10-09 |
| Model Number | K1122 |
| Catalog Number | K1122 |
| Lot Number | 1976227 |
| Device Expiration Date | 2020-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | COLUMBIA MD 21045 US 21045 |
| Brand Name | BUBBLE GUM SCENTED AMBU KING MASK |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2018-10-09 |
| Model Number | K1122 |
| Catalog Number | K1122 |
| Lot Number | 1976227 |
| Device Expiration Date | 2020-01-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | COLUMBIA MD 21045 US 21045 |
| Brand Name | BUBBLE GUM SCENTED AMBU KING MASK |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2018-10-09 |
| Model Number | K1122 |
| Catalog Number | K1122 |
| Lot Number | 1976227 |
| Device Expiration Date | 2020-01-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | COLUMBIA MD 21045 US 21045 |
| Brand Name | BUBBLE GUM SCENTED AMBU KING MASK |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2018-10-09 |
| Model Number | K1122 |
| Catalog Number | K1122 |
| Lot Number | 1976227 |
| Device Expiration Date | 2020-01-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | COLUMBIA MD 21045 US 21045 |
| Brand Name | BUBBLE GUM SCENTED AMBU KING MASK |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2018-10-09 |
| Model Number | K1122 |
| Catalog Number | K1122 |
| Lot Number | 1976227 |
| Device Expiration Date | 2020-01-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | COLUMBIA MD 21045 US 21045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-09 |