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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATOR

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ST PAUL PNEUPAC VENTILATOR Back to Search Results
Model Number BABY PAC
Device Problem Defective Alarm (1014)
Patient Problem No Information (3190)
Event Type  Malfunction  
Event Description

Information received a smiths medical ventilators|pneupac ventilators babypac revealed out of box failure: unit is not showing alarms, lights in cpap plus imv modes , does not maintain peep in cmv and peep. No patient adverse events reported.

 
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Brand NamePNEUPAC
Type of DeviceVENTILATOR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
receiving dock
minneapolis, MN 55442
MDR Report Key10983981
MDR Text Key220682873
Report Number3012307300-2020-12266
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK970158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberBABY PAC
Device Catalogue Number150003
Was Device Available For Evaluation? No
Date Returned to Manufacturer11/25/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/28/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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