MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-05 for PEDI CPR MASK WITH RESERVOIR TUBE NO PEEP 2K8008 manufactured by Carefusion 2200 Inc.
[48725054]
Patient Sequence No: 1, Text Type: N, H10
[48725055]
While getting off the elevator to transport patient to room, patient coughed and it was noted that her et tube had been displaced. So crna and surgeon than began to try to ventilate patient with mask/ambu bag and it was noted that there was no air exchange. It was than noted that the mask was in the trash and when obtained it appeared to be stepped on because there was a large hole that was not there prior. This is what the patient safety report stated: upon transport to the picu from outpatient surgery, the patient's endotracheal tube became dislodged when the patient coughed. Patient and team were preparing to come off the elevator in the picu when the tube was noted to be in place. At that point the patient was bagged with mask/ambu bag and immediately ran into room where picu staff were waiting. Upon trying to bag the patient, it was noted that the mask had a crack in it and therefore adequate air exchange was not happening, and so a new mask was exchanged out. Picu staff were then able to eventually gain adequate spo2 and able to then reintubate patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5768622 |
| MDR Report Key | 5768622 |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-05-26 |
| Report Date | 2016-06-30 |
| Date Reported to FDA | 2016-06-30 |
| Date Reported to Mfgr | 2016-06-30 |
| Date Added to Maude | 2016-07-05 |
| 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 | PEDI CPR MASK WITH RESERVOIR TUBE NO PEEP |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | CBP |
| Date Received | 2016-07-05 |
| Catalog Number | 2K8008 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200 INC |
| Manufacturer Address | 5 SUNNEN DR. SAINT LOUIS MO 63143 US 63143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-05 |