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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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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.
 
Manufacturer Narrative
Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.D4: complete udi - (b)(4).One device was received.No physical damage.The complaint was confirmed/duplicated.The o2 concentration is out of specification.The cause was the device was out of specification over time; the source was unknown.Recalibrated 02 concentration.Replaced o-rings, battery, and sintered filter.Recalibrated peep needle.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint., corrected data: h6.Health effects; corrected.
 
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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,Followup
Report Date 07/03/2024
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
Device Operator Health Professional
Device Catalogue NumberP310NUS
Was Device Available for Evaluation? No
Date Returned to Manufacturer10/30/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/26/2023
Initial Date FDA Received11/13/2023
Supplement Dates Manufacturer Received06/20/2024
Supplement Dates FDA Received07/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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