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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 Problem Failure to Cycle (1142)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2023
Event Type  malfunction  
Event Description
It was reported that the oxygen ball would not move.No patient involvement.
 
Manufacturer Narrative
Other text: 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.
 
Manufacturer Narrative
Udi updated - (b)(4).Evaluation codes updated.Device evaluation: one device was received.A visual inspection found a stuck gas supply indicator, the eyeball was dislodged from the assembly, the housing contained impact marks on the bottom and around the battery compartment, all 3 small knobs were missing and the manometer needle was out of spec.During the functional testing, it was confirmed that the gas supply indicator was stuck and did not move.It was determined that the cause was from an impact to the device.The damaged gas supply indicator set was replaced as well as the mri battery, sintered filter, o'rings, gas supply indicator set, missing control knobs and end caps and the pressure manometer.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in, please direct those to the following: (b)(6).
 
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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 Key18125909
MDR Text Key328009491
Report Number3012307300-2023-10483
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,Followup
Report Date 06/26/2024
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 Number120003
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/01/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/13/2023
Supplement Dates Manufacturer Received02/09/2024
Supplement Dates FDA Received06/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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