MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS 2K8032 manufactured by Carefusion/bd.
[69557004]
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
[69557005]
Customer reported that "during patient ventilation, patient being ventilated with bag and mask and when intubation is being performed realizing that the mask does not come of the elbow in order to attach to the endotracheal tube. No patient injury, because they changed to another bag".
Patient Sequence No: 1, Text Type: D, B5
[74374276]
Follow up submission: no sample was provided for evaluation. At this time we are unable to confirm the reported issue. However, based on similar complaint investigations, a probable root cause is related to the current mirror finish surface on the elbow, which makes the mask very difficult to remove. Capa was opened to further investigate this issue. Capa (b)(4). The elbow will now contain a textured finish to allow the mask to be easily removed from the elbow.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00297 |
| MDR Report Key | 6393454 |
| Date Received | 2017-03-09 |
| Date of Report | 2017-04-26 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-03-09 |
| 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 N. FAIRWAY DR. |
| 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 | 3 |
| Brand Name | RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS |
| Generic Name | MANUAL EMERGENCY VENTILATOR |
| Product Code | OEV |
| Date Received | 2017-03-09 |
| Catalog Number | 2K8032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-03-09 |