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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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ST PAUL PNEUPAC VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number 120003
Device Problem Medical Gas Supply Problem (2985)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Returned device was received in good physical condition.During the evaluation of the device, the device would not cycle.The dump valve was found to be loose.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
Event Description
Information was received indicating that a smiths medical ventilator was not venting with oxygen.There were no patient present at the time of the event.There were no reported adverse events.
 
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Brand Name
PNEUPAC VENTILATOR
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11916212
MDR Text Key253775731
Report Number3012307300-2021-05353
Device Sequence Number1
Product Code BTL
UDI-Device Identifier10610586045486
UDI-Public10610586045486
Combination Product (y/n)N
PMA/PMN Number
K020899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number120003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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