MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-29 for AIRLIFE 2K8805 2K8005 manufactured by Carefusion Corporation.
[71119332]
Patient Sequence No: 1, Text Type: N, H10
[71119333]
Patient was being bag/mask ventilated; once endotracheal tube placed, attempted to remove mask from the resuscitation bag and the mask was unable to be removed from the resuscitation bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6442159 |
| MDR Report Key | 6442159 |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-22 |
| Date of Event | 2017-03-09 |
| Report Date | 2017-03-17 |
| Date Reported to FDA | 2017-03-17 |
| Date Reported to Mfgr | 2017-03-17 |
| Date Added to Maude | 2017-03-29 |
| 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 |
| 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 | BTM |
| Date Received | 2017-03-29 |
| Model Number | 2K8805 |
| Catalog Number | 2K8005 |
| Lot Number | 0001030580 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION CORPORATION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Brand Name | AIRLIFE |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-03-29 |
| Model Number | 2K8805 |
| Catalog Number | 2K8005 |
| Lot Number | 0001030580 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION CORPORATION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-29 |