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: SMITHS MEDICAL ASD,INC VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
  • 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
 

SMITHS MEDICAL ASD,INC VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number ADULT RESUSITATOR, ADULT MASK, BAG, OXY. RESERVOIR, FLOW DIVERTER 12/CA
Device Problem Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 06/01/2020
Event Type  malfunction  
Event Description
Information received a smiths medical breathing|portex manual resuscitation 1st response adult resuscitators non -breathing valve jammed and did not allow the exhalation of oxygen air being delivered in to the airway.A video was provided to replay incident.No adverse patient events were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Type of Device
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC
6000 nathan lane
minneapolis, mn
MDR Report Key10235431
MDR Text Key198289787
Report Number3012307300-2020-06650
Device Sequence Number1
Product Code BTM
UDI-Device Identifier00351688431219
UDI-Public0351688431219
Combination Product (y/n)N
PMA/PMN Number
K014115
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberADULT RESUSITATOR, ADULT MASK, BAG, OXY. RESERVOIR, FLOW DIVERTER 12/CA
Device Catalogue Number8500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Date Manufacturer Received06/08/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-