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 2017-12-01 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Vyaire Medical, Inc.
[93496472]
(b)(4). It has been confirmed by the medwatch that the complaint sample is not available for evaluation. An attempt has been made by vyaire to gain additional information and a representative sample from the same lot number from the customer. Vyaire is still waiting for additional information regarding reported issue. If a sample or any additional information becomes available after all due diligence attempts have been completed a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[93496473]
Per medwatch report (b)(4). Could not feel or hear oxygen through bag/valve mask. Attempted to use bag/valve mask on patient and even with good seal and chest rise the patients o2 sats would not improve, noticed that we could not feel the oxygen flow or hear it through the bag/valve mask. This occurred during general anesthesia for repair of a left popliteal artery. Hospital provided patient identifier (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00391 |
| MDR Report Key | 7075339 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-12-01 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-11-27 |
| Date Added to Maude | 2017-12-01 |
| 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 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION 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 | 2017-12-01 |
| Catalog Number | 2K8005 |
| Lot Number | 001086128 |
| 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 | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-01 |