MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-05-03 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Carefusion/bd.
[74318572]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74318573]
Customer reported the following via medwatch (b)(4). Customer reported that the "patient was being bag/mask ventilated; once endotracheal tube placed, attempted to remove mask from the resuscitation bag and the mask was unable to be removed from the resuscitation bag".
Patient Sequence No: 1, Text Type: D, B5
[90801924]
Unfortunately the sample was never returned to vyaire for further evaluation. At this time the reporter unable to disconnect failure mode cannot be confirmed without the device sample. However based on similar complaints a probable root cause is considered to be the mirror finish surface on the elbow making the mask very difficult to remove. A new textured surface finish has been implemented on the elbows allowing the mask to be easily removed.
Patient Sequence No: 1, Text Type: N, H10
[90801925]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00332 |
| MDR Report Key | 6541335 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-05-03 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-05-03 |
| 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 | 3 |
| Brand Name | RESUS, ADLT W/MASK, 40" TBG, 6/CS |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-05-03 |
| Catalog Number | 2K8005 |
| Lot Number | 0001030580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-05-03 |