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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS VENTIPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS VENTIPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Catalog Number 130003
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
Operator of device 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 patient circuit connector was too loose and wouldn't work correctly, causing internal leakage.There was no patient involvement and no patient harm/adverse event reported.
 
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Brand Name
PNEUPAC VENTILATORS VENTIPAC
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
3350 granada ave n, suite 100
oakdale MN 55128
Manufacturer Contact
reed covert
6000 nathan lane n
minneapolis, MN 55442
2247062300
MDR Report Key18610466
MDR Text Key334512005
Report Number2183161-2024-00119
Device Sequence Number1
Product Code BTL
UDI-Device Identifier10610586038259
UDI-Public10610586038259
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number130003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2024
Date Manufacturer Received01/05/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/11/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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