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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PNEUPAC VRI AHA VENTILATOR WITH REGULATOR AND CIRC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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ST PAUL PNEUPAC VRI AHA VENTILATOR WITH REGULATOR AND CIRC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Catalog Number 520A1299US
Device Problem Failure to Cycle (1142)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Other text: b3: date of event, d4: udi section unknown, and g5: 510k are unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that the device will not cycle and needs preventive maintenance.Patient involvement is unknown.
 
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Brand Name
PNEUPAC VRI AHA VENTILATOR WITH REGULATOR AND CIRC
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17492530
MDR Text Key320780756
Report Number3012307300-2023-07954
Device Sequence Number1
Product Code BZL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number520A1299US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2023
Was the Report Sent to FDA? No
Date Manufacturer Received07/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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