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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PNEUPAC PARAPAC MEDIC MODEL; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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ST PAUL PNEUPAC PARAPAC MEDIC MODEL; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Catalog Number 120003
Device Problems Break (1069); Battery Problem (2885)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Other, other text: b3: date of event is 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's case where the battery goes, looks damaged.Patient involvement is unknown.
 
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Brand Name
PNEUPAC PARAPAC MEDIC MODEL
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 Key17464093
MDR Text Key320440529
Report Number3012307300-2023-07817
Device Sequence Number1
Product Code BTL
UDI-Device Identifier10610586045486
UDI-Public10610586045486
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020899
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 08/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number120003
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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