MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-31 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Vyaire Medical, Inc.
[76371248]
Vyaire medial has reached out to the customer multiple times to obtain the impacted device and additional information. At this time the customer has responded stating they have the device quarantined and "that they cannot release the defective product due to the severity of the situation". Vyaire is attempting to evaluate the impacted device on site. Vyaire is still waiting for the customers response if they will be willing to allow an onsite inspection of the impacted device. If a device or any additional information becomes available a follow up emdr will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76371249]
Customer reported that "the resuscitation bag did not inflate/deflate while in patient use. The patient died. The valve in the rear of the device was folded over and allowed air to escape through the back as the device was squeezed. The clinical story is basically that the patient needed intubation, they connected the resuscitation bag and there was no chest rise. They verified intubation and re-intubated the patient with a glidescope and tube placement was verified that way. Still no chest rise and they tried other things and finally switched out the resuscitation bag. The patient in the meantime coded and died. Customer has stated that they have filed a medwatch the number has not been reported to vyaire at this time.
Patient Sequence No: 1, Text Type: D, B5
[106053188]
Device evaluation: on august 17, 2017, the product engineering director and vyaire? S outside legal counsel visually inspected the resuscitation bag at temecula valley hospital. This complaint will be closed pending legal counsel involvement. If any additional information becomes available the complaint will be re-opened to include that information as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00338 |
| MDR Report Key | 6603172 |
| Date Received | 2017-05-31 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-04-27 |
| Date Mfgr Received | 2017-10-21 |
| Date Added to Maude | 2017-05-31 |
| 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 | 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 | 2017-05-31 |
| Catalog Number | 2K8005 |
| Lot Number | 0001040664 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Death | 2017-05-31 |