MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for AIRLIFE 2K8005 manufactured by Carefusion.
[91826834]
Patient Sequence No: 1, Text Type: N, H10
[91826837]
Could not hear or feel any oxygen flow through bag/valve mask. Attempted to use bag/valve mask on patient and even with good seal and chest rise the patient's o2 sats would not improve noticed that we could not feel the oxygen flow or hear it through the bag/valve mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7024845 |
| MDR Report Key | 7024845 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-11 |
| Report Date | 2017-10-20 |
| Date Reported to FDA | 2017-10-20 |
| Date Reported to Mfgr | 2017-10-20 |
| Date Added to Maude | 2017-11-13 |
| 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 | OEV |
| Date Received | 2017-11-13 |
| Model Number | 2K8005 |
| Catalog Number | 2K8005 |
| Lot Number | 0001086128 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Brand Name | AIRLIFE |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-11-13 |
| Model Number | 2K8005 |
| Catalog Number | 2K8005 |
| Lot Number | 0001086128 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-13 |