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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTILATOR; ENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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VENTILATOR; ENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number VR1 STANDARD
Medical Device Problem Codes Break (1069); Power Problem (3010)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/01/1901
Type of Reportable Event Malfunction
Event or Problem Description
Information received a smiths medical ventilators|pneupac ventilators vr1 standard breaking push button, no patient adverse event or involvement.
 
Additional Manufacturer Narrative
Other, other text: device evaluation- the device was examined.The device had a missing push button.The input hose connection had loose particles and dirty housing.The gaiter was also torn.The physical characteristics were determined consistent with the device having sustained impact damage.
 
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Brand Name
VENTILATOR
Common Device Name
ENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key10220645
Report Number3012307300-2020-06500
Device Sequence Number2405001
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 Other
Type of Report Initial,Followup
Report Date (Section B) 10/02/2020
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 Other
Device Model NumberVR1 STANDARD
Device Catalogue Number520A1299US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/03/2020
Supplement Date Received by Manufacturer09/11/2020
Initial Report FDA Received Date07/01/2020
Supplement Report FDA Received Date10/01/2020
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 Initial
Patient Sequence Number1
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