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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 delivered one breath and then nothing further.There were no reported adverse effects.
 
Manufacturer Narrative
Device evaluation- the device was returned for evaluation.The device was given functional testing; this showed the demand detector block was faulty which caused the device not to cycle as expected.Once the demand detector block was replaced the device met with specifications.
 
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Brand Name
PNEUPAC® PARAPAC® VENTILATOR
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key9613572
MDR Text Key176883512
Report Number3012307300-2020-00318
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 04/04/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Initial Date Manufacturer Received 12/26/2019
Initial Date FDA Received01/21/2020
Supplement Dates Manufacturer Received03/06/2020
Supplement Dates FDA Received04/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2013
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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