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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PNEUPAC; VENTILATOR
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PNEUPAC; VENTILATOR Back to Search Results
Model Number 130003V
Medical Device Problem Code Gas/Air Leak (2946)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/06/2021
Type of Reportable Event Malfunction
Event or Problem Description
Information received a smith medical ventilators|pneupac ventilators ventipac malfunctioned.Reported air is leaking and gauge is off.Inspiratory knob is catching on something.Event occurred during testing and no patient involvement.
 
Additional Manufacturer Narrative
Other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.There is no pressure on the manometer when backpressure is applied.The inspiratory knob rubs on the ribbon cable.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
Common Device Name
VENTILATOR
MDR Report Key12263609
Report Number3012307300-2021-07963
Device Sequence Number16922155
Product Code BTL
UDI-Device Identifier35019315074183
UDI-Public35019315074183
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K030803
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/11/2021
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
Operator of Device No Information
Device Model Number130003V
Device Catalogue Number130003V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/06/2021
Supplement Date Received by Manufacturer08/03/2021
Initial Report FDA Received Date08/02/2021
Supplement Report FDA Received Date08/11/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured04/11/2006
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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