MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for AIRLIFE 2K8036 manufactured by Carefusion Corporation.
[116299519]
During mock codes, there have been multiple instances where the white cap that covers the monitoring side port on the mechanical resuscitator (ambu bag) opens. This results in ineffective bagging as the "as" goes through the port rather than to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7758312 |
| MDR Report Key | 7758312 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-07-16 |
| Report Date | 2018-07-17 |
| Date Reported to FDA | 2018-07-17 |
| Date Reported to Mfgr | 2018-08-07 |
| Date Added to Maude | 2018-08-07 |
| 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 | AIRLIFE |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2018-08-07 |
| Model Number | 2K8036 |
| Catalog Number | 2K8036 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION CORPORATION |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-07 |