MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-12 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Carefusion/bd.
[75088622]
It has been confirmed by carefusion/bd that the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. If a sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75088623]
The customer reported:? After a successful intubation, i could not remove the mask from the bag valve mask (bvm). I handed the bvm to a co-worker whom also struggled to remove the mask from the bvm. I went to grab another bvm but he was then able to free the mask from the bvm?. The customer did not provide any information regarding patient consequence as a result of the reported issue, it is currently unknown.
Patient Sequence No: 1, Text Type: D, B5
[110609069]
Additional information: unfortunately the device sample was not available for further investigation. At this time the unable to disconnect failure mode cannot be confirmed. However based on similar complaints as a probable root cause it is considered that the current mirror finish surface on the elbow makes the mask very difficult to remove. The new textured surface finish on the elbow allows the mask to be easily removed as indented. A corrective and preventative action has also been opened to further investigate into this known failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00333 |
| MDR Report Key | 6564700 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-12 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-05-12 |
| 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 |
| 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 |
| Removal Correction Number | 8030673-4/27/17-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESUS, ADLT W/MASK, 40" TBG, 6/CS |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-05-12 |
| Catalog Number | 2K8005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-05-12 |