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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PNEUPAC PARAPAC VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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PNEUPAC PARAPAC VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number 120003
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical pneupac parapac ventilator did ventilate when on the patient.There were no reported adverse effects.
 
Manufacturer Narrative
Other, other text: one pneupac ventilator was returned for analysis due to not ventilating on the patient.The device was connected to o2 supply and ran the device on various settings for a period of 1 hour.The reported issue was no confirmed.The issue could be a faulty demand detector causing intermittent cycling.The issue was attributed to normal wear and tear due to age of the device.
 
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Brand Name
PNEUPAC PARAPAC VENTILATOR
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key10203421
MDR Text Key196735749
Report Number3012307300-2020-06286
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,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number120003
Device Catalogue Number120003
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/19/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/03/2020
Initial Date FDA Received06/26/2020
Supplement Dates Manufacturer Received08/24/2020
Supplement Dates FDA Received09/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2006
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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