• 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 Disconnection (1171)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)
Event Date 11/06/2017
Event Type  Death  
Manufacturer Narrative
One open sample was received for evaluation. After performing a visual inspection to the affected sample it was observed that the tube was detached from the threaded o2 housing. Both components showed a poor evidence of solvent. It is considered that assembly personnel are related to the disconnection of the resuscitator by applying an inadequate amount of the solvent on the union between the pvc tubing and the housing for a complete assembly of the product. Since the defect was provoked due to a lack of solvent, personnel were re-trained and notified about this issue.
 
Manufacturer Narrative
Currently awaiting for the sample. Once the investigation is complete a follow up submission will be filed.
 
Event Description
Md was attempting a stat intubation in ed. The ambu bag with mask was attached to wall o2 at 15 l/ 100%. As the md attempted to use the bag with mask on the patient prior to intubation, the internal o2 tubing disconnected from the bag. The o2 tubing was not able to be reconnected to the bag. The patient presented to the trauma bay of the ed and needed emergency intubation due to their status. The clinicians were bagging the patient and noticed they were unable to stabilize the patient as the patient was desaturating and hypotensive. While bagging the patient, the clinician noticed that the oxygen tubing had become disconnected from the resuscitative device and was unable to be reinserted to continue bagging. Another device was grabbed and was successful at ventilating the patient. The patient was easily intubated and ventilated. However, later in the course of the stay at ed, the patient ended up crashing and coding and eventually expired.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESUS, ADLT W/MASK, 40" TBG, 6/CS
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL, INC
26125 n. riverwoods blvd
mettewa IL 60045
Manufacturer (Section G)
VYAIRE MEDICAL, INC
cerrada via de la produccion
no. 85., parque industrial mex
mexicali baja california norte
MX
Manufacturer Contact
mindy faber
26125 n riverwoods blvd
mettawa, IL 60045
MDR Report Key7049414
MDR Text Key106171732
Report Number8030673-2017-00384
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/21/2017 Patient Sequence Number: 1
-
-