MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8036 manufactured by Vyaire Medical, Inc.
[75815980]
It has been confirmed by (b)(4) 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
[75815981]
Customer reported that the "bag was pulled out to use on the patient. It seemed deformed on the blue part of the bag where you squeeze to provide ventilation. When attached to oxygen, the bag would not inflate and could not be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00337 |
| MDR Report Key | 6586498 |
| Date Received | 2017-05-23 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-04-24 |
| Date Mfgr Received | 2017-04-24 |
| Date Added to Maude | 2017-05-23 |
| 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 | 2017-05-23 |
| Catalog Number | 2K8036 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-05-23 |