MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-11 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Carefusion/bd.
[69738164]
(b)(4) has reached out to customer three times to provide the complaint device for further investigation. A (b)(6) label was also provided to the customer each time. Unfortunately, (b)(4) has not received the complaint device for evaluation or the requested additional information. 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
[69738165]
Customer reported the following "we have also heard other scenarios when a patient was brought in intubated, a new bag/mask (always attached in the bag) was opened and they were unable to provide ventilation/oxygenation. There was a delay until another bag could be retrieved or the mask was dislodged by someone. "
Patient Sequence No: 1, Text Type: D, B5
[74375627]
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 | 8030673-2017-00304 |
| MDR Report Key | 6397910 |
| Date Received | 2017-03-11 |
| Date of Report | 2017-04-26 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-04-20 |
| Date Added to Maude | 2017-03-11 |
| 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/MASK, 40" TBG, 6/CS |
| Generic Name | MANUAL EMERGENCY VENTILATOR |
| Product Code | OEV |
| Date Received | 2017-03-11 |
| Catalog Number | 2K8005 |
| 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 | 2017-03-11 |