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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PNEUPAC; VENTILATOR
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PNEUPAC; VENTILATOR Back to Search Results
Model Number 130003
Device Problem Medical Gas Supply Problem (2985)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Information received a smiths medical ventilators|pneupac ventilators ventipac has problem with oxygen mix.No patient adverse events reported.
 
Manufacturer Narrative
Other text: investigation completed on a smiths medical ventilators|pneupac ventilators ventipac complaint of problem with oxygen mix was verified.Device physical condition revealed missing knobs off and on along with out of spec manometer, missing end cap for the airmix knob, and a missing shroud cap for the gas supply indicator.When testing inspiratory and expiratory times were out of specification.Action was taken to replace replaced damaged oring on the airmix poppet seat, calibrated ins/exp.Replaced damaged oring on the airmix poppet seat, calibrated ins/exp.To correct the customer reported reason.Replaced manometer, faulty variable relief valve, airmix knob and shroud cap.Installed pm kit.Performed pm testing, cleaned and affixed service label.
 
Event Description
Device evaluation completed and summary in h10.
 
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Brand Name
PNEUPAC
Type of Device
VENTILATOR
MDR Report Key12054444
MDR Text Key258037393
Report Number3012307300-2021-06469
Device Sequence Number1
Product Code BTL
UDI-Device Identifier10610586038259
UDI-Public10610586038259
Combination Product (y/n)N
PMA/PMN Number
K030803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number130003
Device Catalogue Number130003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2010
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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