MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for AMBU KING MASK/DISPOSABLE ANESTHESIA FACE MASK manufactured by Ambu A/s.
[137058451]
During resuscitation cpap mask went completely flat, making it extremely difficult to maintain a seal for infant. Prior to delivery, mask was checked by 3 nurses including this rn and the nicu rn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084075 |
| MDR Report Key | 8343158 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-02-06 |
| Date Added to Maude | 2019-02-15 |
| 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 | AMBU KING MASK/DISPOSABLE ANESTHESIA FACE MASK |
| Generic Name | MASK, GAS, AHESTHETIC |
| Product Code | BSJ |
| Date Received | 2019-02-14 |
| Lot Number | 1000181222 |
| 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 | BALLERUP.DK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-02-14 |