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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PNEUPAC DISPOSABLE CIRCUITS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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SMITHS MEDICAL ASD; INC. PNEUPAC DISPOSABLE CIRCUITS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number 100/905/340-CH
Medical Device Problem Code Increase in Pressure (1491)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that a high-pressure warning sounded when a smiths medical pneupac¿ disposable circuit when connected to a ventilator.The product was changed out and the ventilator worked as intended.It was reported that this occurred during pre-use test with no reported patient injury.
 
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Brand Name
PNEUPAC DISPOSABLE CIRCUITS
Common Device Name
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, mn
MDR Report Key10025192
Report Number3012307300-2020-03696
Device Sequence Number19612103
Product Code BTL
UDI-Device Identifier15019517160215
UDI-Public15019517160215
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K123957
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/05/2020
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 No Information
Device Expiration Date10/02/2020
Device Model Number100/905/340-CH
Device Catalogue Number100/905/340-CH
Device Lot Number190826
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/07/2020
Initial Report FDA Received Date05/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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