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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTILATORS PNEUPAC VENTILATORS VENTIPAC .; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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VENTILATORS PNEUPAC VENTILATORS VENTIPAC .; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number VENTILATOR ASM VENTIPAC W/ALRMS PNEUPAC 1/EA
Device Problem Medical Gas Supply Problem (2985)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Information received a smiths medical ventilators|pneupac ventilators ventipac malfunction.It was discovered that patient assembly outlet was missing when setting up device.The unit was due for pm after discovering it will not drop 50% when setting air mix setting and keeps delivering 90%.Issue discovered prior to patient use, so no patient injury or involvement.
 
Manufacturer Narrative
Device evaluation- the device was returned for evaluation.The examination of the returned device showed the patient outlet connector was missing.After the patient outlet connector was replaced the device passed the oxygen concentration testing.
 
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Brand Name
VENTILATORS PNEUPAC VENTILATORS VENTIPAC .
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key9576203
MDR Text Key176685614
Report Number3012307300-2020-00134
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 distributor,health profession
Type of Report Initial,Followup
Report Date 04/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVENTILATOR ASM VENTIPAC W/ALRMS PNEUPAC 1/EA
Device Catalogue Number130003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Date Manufacturer Received03/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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