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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 520A1299US
Medical Device Problem Code Failure to Cycle (1142)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Event or Problem Description
Information received a smiths medical ventilators|pneupac ventilators vr1 standard it will not cycle, as it has contestant pressure in adult mode.
 
Additional Manufacturer Narrative
Other, other text: investigation completed on a smiths medical ventilators|pneupac ventilators vr1 standard report of not cycling with constant pressure in adult mode was confirmed during testing.This was isolated to a fault rolling diaphragm.The physical condition revealed a crack in the upper case.Repair summary: replaced faulty rolling diaphragm to correct the customer reported problem.Replaced defective patient valve assembly and crack upper case.Installed service kit.Performed pm testing, cleaned and affixed service label.
 
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Brand Name
PNEUPAC
Common Device Name
VENTILATOR
MDR Report Key12135509
Report Number3012307300-2021-06915
Device Sequence Number17137784
Product Code BTL
UDI-Device Identifier10610586045721
UDI-Public10610586045721
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K051322
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 08/18/2021
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 Health Professional
Device Model Number520A1299US
Device Catalogue Number520A1299US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/09/2021
Supplement Date Received by Manufacturer07/19/2021
Initial Report FDA Received Date07/08/2021
Supplement Report FDA Received Date08/18/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured11/05/2012
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 Unknown
Patient Sequence Number1
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