MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-26 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Carefusion/bd.
[73785684]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73785685]
Customer reported the following directly to carefusion/bd "adapter/tube detached from coupler so the correct oxygen flow wasn't going to the patient. There was patient involvement, no patient harm". Carefusion/bd received medwatch report (b)(4). Customer reported? Self-inflating ventilation bag was connected to oxygen source and patient was ventilated after intubation. The patient experienced decreasing oxygen saturation despite ventilation. Troubleshooting the issue revealed that the oxygen tubing had disconnected from the connection to the bag, which is inside a corrugated reservoir tubing. The patient was not receiving additional oxygen as intended. The equipment issue was found quickly, and new equipment was readily available, swapped out and the patient responded quickly there was no patient harm?.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00327 |
| MDR Report Key | 6524870 |
| Date Received | 2017-04-26 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-03-25 |
| Date Mfgr Received | 2017-07-03 |
| Date Added to Maude | 2017-04-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION/BD |
| Manufacturer Street | CERRADA V NO.85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESUS, ADLT W/MASK, 40" TBG, 6/CS |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-04-26 |
| Returned To Mfg | 2017-04-13 |
| Catalog Number | 2K8005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION/BD |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO. 85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-26 |