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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 Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical pneupac® parapac® ventilator would not ventilate the patient.It was reported that it would only intermittently ventilate.There were no reported adverse effects.
 
Manufacturer Narrative
Device evaluation: one smiths medical pneupac parapac ventilator was returned for analysis undamaged.During analysis, the reported issue was unable to be duplicated.Service replaced the oscillator block as a preventative measure.Based on the evidence, the complaint was not confirmed, and no fault was found.
 
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Brand Name
PNEUPAC® PARAPAC® VENTILATOR
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key9623902
MDR Text Key177389963
Report Number3012307300-2020-00741
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 04/08/2020
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
Device Lot Number0604322
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Initial Date Manufacturer Received 01/02/2020
Initial Date FDA Received01/23/2020
Supplement Dates Manufacturer Received03/12/2020
Supplement Dates FDA Received04/08/2020
Was Device Evaluated by Manufacturer? Yes
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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