MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for AIRLIFE 2K8005 manufactured by Carefusion Corporation.
[93499541]
Patient Sequence No: 1, Text Type: N, H10
[93499542]
Md was attempting a stat intubation in er. The ambu bag with mask was attached to wall o2 at 15l/ 100%. As the md attempted to use the bag with mask on the patient prior to intubation, the internal o2 tubing disconnected from the bag. Unfortunately, due to the design of the bag the o2 tubing was not able to be reconnected to the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7074494 |
| MDR Report Key | 7074494 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-11-02 |
| Report Date | 2017-11-06 |
| Date Reported to FDA | 2017-11-06 |
| Date Reported to Mfgr | 2017-11-06 |
| Date Added to Maude | 2017-12-01 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | AIRLIFE |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | LIX |
| Date Received | 2017-12-01 |
| Model Number | 2K8005 |
| Lot Number | 0001121461 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-12-01 |