MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-06 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Vyaire Medical, Inc.
[76820868]
Carefusion has reached out to the customer to obtain sample for investigation. Ups label was provided to the customer. At this time, carefusion has not received the suspect device. If the device is returned, an investigation will be performed, and a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76820869]
The customer reported that while using the adult resuscitation device, "the elbow wouldn't separate from the mask. They were able to resuscitate using the same resuscitation bag in and upright vertical position if they removed the elbow or through the mask, as the 15mm connection to mate to the endotracheal tube had enough clearance to pass through and seal. No patient/caregiver injury/death. "
Patient Sequence No: 1, Text Type: D, B5
[113290910]
One opened sample was returned for further evaluation. A visual inspection was performed and it was observed that the sample did not exhibit the textured surface finish on the connectors outer diameter. The textured surface makes it easier to detach the mask form the elbow. The prior design had a smooth mirror finish as exhibited on this sample. It was found that this mirror finish on the elbow and the smooth finish on the mask can create a vacuum effect making the removal of the mask difficult. A design change has been made to this product adding the texturized surface to the elbow eliminating the difficult remove failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00340 |
| MDR Report Key | 6616965 |
| Date Received | 2017-06-06 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-05-07 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-06-06 |
| 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 | 26125 N. RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| 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 | 2017-06-06 |
| Returned To Mfg | 2017-07-21 |
| Catalog Number | 2K8005 |
| Lot Number | 0001014036 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| 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 | 2017-06-06 |