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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS VR1 STANDARD; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

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SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS VR1 STANDARD; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Catalog Number VR1STDNJJP
Device Problems Failure to Cycle (1142); Communication or Transmission Problem (2896)
Patient Problem Insufficient Information (4580)
Event Date 12/01/2023
Event Type  malfunction  
Manufacturer Narrative
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 during patient use the product cannot switch to manual and automatic.Adverse patient effects are unknown.
 
Manufacturer Narrative
Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.The complaint was verified by visual and functional testing.The dial could not be locked on the automatic side due to deformation of the dial momentary (automatic/manual switching knob).The cause was a deformation of dial momentary (automatic/manual switching knob).It was unknown what caused the condition.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.Replaced the dial momentary (automatic/manual switching knob) to correct the issue.The device passed all functional tests and delivery tests after repair.
 
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Brand Name
PNEUPAC VENTILATORS VR1 STANDARD
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18480459
MDR Text Key332879739
Report Number3012307300-2024-00177
Device Sequence Number1
Product Code BTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/19/2024
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 NumberVR1STDNJJP
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/14/2023
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received01/09/2024
Supplement Dates Manufacturer Received01/21/2024
Supplement Dates FDA Received02/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2022
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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