• 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 AIRLIFE ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER 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 AIRLIFE ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number AIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative
The suspect device or picture has not been returned for evaluation. Therefore, root cause has not been determined. Additionally, a device history record (dhr) of the lot number revealed no issues. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The customer reported that the oxygen tubing got disconnected from the wall (o2 source) when the o2 pressure increased. A gas leak was then observed from the airlife adult manual resuscitator. It happened during patient use, and the insufflator was replaced with a different brand. The incident did not cause any harm but did delay treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAIRLIFE ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada v?a de la producci?n
85 parque undustrial mex iii
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, il 
MDR Report Key10176899
MDR Text Key196431556
Report Number8030673-2020-00098
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER
Device Catalogue Number2K8004F
Device Lot Number0004075326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
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

Patient Treatment Data
Date Received: 06/19/2020 Patient Sequence Number: 1
-
-