Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT
  • 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, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8005
Device Problem Pressure Problem (3012)
Patient Problem Low Oxygen Saturation (2477)
Event Date 12/05/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).-vyaire has reached out to customer to provide the complaint device for further investigation.At this time we are currently waiting for the sample.If the customer provides the sample for further investigation or additional information is obtained, vyiare will provided a follow up emdr.
 
Event Description
Customer reported "the diaphragm at the gas inlet of the bag was not in place and we were unable to ventilate with the bag".The clinician became aware of the issue due to the spo2 not increasing.Customer reported that there was no patient harm.
 
Manufacturer Narrative
The vyaire failure analysis lab received the suspected device/component and performed a failure investigation.The reported issue was confirmed in the laboratory setting.The root cause of the reported issue: personnel/training-operator error-assembly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RESUS, ADLT W/MASK, 40" TBG, 6/CS
Type of Device
CARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL, INC
26125 north riverwoods blvd
mettawa IL 60045
MDR Report Key7158545
MDR Text Key96187161
Report Number8030673-2018-00399
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2K8005
Device Lot Number0001121459
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-