• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL RESUS, PED W/MASK, RESV BAG MANUAL EMERGENCY VENTILATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VYAIRE MEDICAL RESUS, PED W/MASK, RESV BAG MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8040
Device Problem Mechanical Problem (1384)
Patient Problem Skin Inflammation (2443)
Event Date 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
Due to limited information, no samples and/or lot numbers were provided by the customer. Vyaire has not received the suspect device/component for evaluation.
 
Event Description
Customer reported: nursing said that they had to use canulaid more often compared to the old version of cannulas. Despite the addition of canulaid, a patient had nasal injuries reported; one with a malformation after therapy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESUS, PED W/MASK, RESV BAG
Type of DeviceMANUAL EMERGENCY VENTILATOR
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
Manufacturer (Section G)
PRODUCTOS URÓLOGOS DE MÉXICO S.A. DE C.V.
cerrada vía de la producción
85 parque undustrial mex iii
mexicali, 21397
MX 21397
Manufacturer Contact
stanley tan
22745 savi ranch pkwy
yorba linda, CA 92887
7149193324
MDR Report Key8278215
MDR Text Key134335803
Report Number8030673-2019-00026
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8040
Device Lot Number0001143879
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

-
-