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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number P310NUS
Device Problem Gas Output Problem (1266)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The reporter stated the device did not give a breath as expected.The issue was identified during testing; no patient involved.
 
Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
PNEUPAC
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key11336136
MDR Text Key232132489
Report Number3012307300-2021-01280
Device Sequence Number1
Product Code BTL
UDI-Device Identifier35019315107263
UDI-Public35019315107263
Combination Product (y/n)N
PMA/PMN Number
K123957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/03/2021
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 Health Professional
Device Model NumberP310NUS
Device Catalogue NumberP310NUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/18/2021
Initial Date FDA Received02/16/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received04/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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