MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-01 for AIRLIFE 2K8080 manufactured by Carefusion 211, Inc.. Dba Carefusion.
[18569831]
During manual ventilation with ambu bag during transport of an intensive care unit (icu) patient from emergency room ct scanner to medical intensive care unit (micu), the respiratory therapist noticed that the positive end expiratory pressure (peep) valve did not fit as tightly as it used to. Then, the peep valve fell off of the ambu bag. The peep valve was set at 15 cm h2o. The patient needed cardiopulmonary resuscitation (cpr) immediately following the loss of the peep valve. The patient was successfully resuscitated. Later, the respiratory therapy manager found out that the peep valve had changed, but the distributor and catalog number were the same (entirely different peep valve than previously stocked peep valve). Distributor never told facility about this change in peep valve. A formal complaint was lodged with the distributor over this oversight and lack of communication. A formal complaint was lodged with carefusion as there was no communication regarding the change of the peep valve product's specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3847300 |
| MDR Report Key | 3847300 |
| Date Received | 2014-05-01 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-02-10 |
| Report Date | 2014-05-01 |
| Date Reported to FDA | 2014-05-01 |
| Date Reported to Mfgr | 2014-06-04 |
| Date Added to Maude | 2014-06-04 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE |
| Generic Name | ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE |
| Product Code | BYE |
| Date Received | 2014-05-01 |
| Model Number | 2K8080 |
| Catalog Number | 2K8080 |
| Lot Number | 131028 |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 211, INC.. DBA CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-01 |