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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

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SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Catalog Number P310NUS
Device Problem Failure to Cycle (1142)
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 oxygen concentration control was not moving.Patient involvement unknown.
 
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Brand Name
PNEUPAC PARAPAC PLUS
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key18124208
MDR Text Key328512271
Report Number3012307300-2023-10468
Device Sequence Number1
Product Code BTL
UDI-Device Identifier35019315107263
UDI-Public35019315107263
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123957
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 11/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberP310NUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2023
Was the Report Sent to FDA? No
Date Manufacturer Received10/26/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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