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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 520A1299US
Medical Device Problem Code Physical Resistance/Sticking (4012)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that the auto and manual dial to a smiths medical pneupac vr1 became stuck.There were no reported adverse effects.
 
Additional Manufacturer Narrative
Returned device was received in good physical condition.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
Common Device Name
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key10479740
Report Number3012307300-2020-08928
Device Sequence Number14091521
Product Code BTL
UDI-Device Identifier10610586045721
UDI-Public10610586045721
Combination Product (Y/N)N
Initial Reporter StateTN
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) 11/16/2020
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
Operator of Device Health Professional
Device Model Number520A1299US
Device Catalogue Number520A1299US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 08/07/2020
Supplement Date Received by Manufacturer10/16/2020
Initial Report FDA Received Date09/01/2020
Supplement Report FDA Received Date11/15/2020
Was Device Evaluated by Manufacturer? (Y/N) Yes
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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