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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) PRODUCT CODE: BTL
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SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) PRODUCT CODE: BTL Back to Search Results
Model Number 530A1167
Device Problems Device Alarm System (1012); Incorrect Measurement (1383); Increase in Pressure (1491)
Patient Problem High Oxygen Saturation (2478)
Event Type  malfunction  
Event Description
Information was received that a smiths medical pneupac parapac plus ventilator over-pressurized the patient.It was also noted that the pressure gauge needle followed the increasing/decreasing pressure adjustments improperly.The relief alarm also exhibited pressure issues.No adverse effects were reported.
 
Manufacturer Narrative
Device evaluation: received device in good condition.Turned device on for initial relief alarm check.Device was within tolerance for both nam and am.Customer reported reason could not be confirmed.Secondary issues found was patient pressure cycling led flashed prematurely and was adjusted.Peep control also measured out of tolerance at the high setting and was adjusted.The customer reported condition was confirmed.Problem source is normal wear and tear.
 
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Brand Name
PNEUPAC PARAPAC PLUS VENTILATOR
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) PRODUCT CODE: BTL
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8609675
MDR Text Key145033472
Report Number3012307300-2019-02698
Device Sequence Number1
Product Code BTL
UDI-Device Identifier35019315107478
UDI-Public35019315107478
Combination Product (y/n)N
PMA/PMN Number
K123957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Type of Report Initial,Followup
Report Date 09/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number530A1167
Device Catalogue Number530A1167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Date Manufacturer Received08/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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