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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB A SUNMED BRAND VENTLAB A SUNMED BRAND AIRFLOW MANUAL RESUSCITATOR/VENT

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VENTLAB A SUNMED BRAND VENTLAB A SUNMED BRAND AIRFLOW MANUAL RESUSCITATOR/VENT Back to Search Results
Lot Number 304805
Device Problems Disconnection (1171); Material Separation (1562)
Patient Problem No Information (3190)
Event Date 07/06/2016
Event Type  Injury  
Event Description
Manual resuscitation/ventilator bag prepared with mask and patient bag/mask ventilated. Upon intubation of patient, respiratory therapist was unable to disconnect mask from the bag valve in order to ventilate via endotracheal tube. Required an unreasonable amount of effort to separate mask from bag valve.
 
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Brand NameVENTLAB A SUNMED BRAND
Type of DeviceAIRFLOW MANUAL RESUSCITATOR/VENT
Manufacturer (Section D)
VENTLAB A SUNMED BRAND
grand rapids MI 49544
MDR Report Key5808420
MDR Text Key50079337
Report NumberMW5063527
Device Sequence Number1
Product Code BTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number304805
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/15/2016 Patient Sequence Number: 1
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