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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL ONE; WARMING

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ST PAUL LEVEL ONE; WARMING Back to Search Results
Catalog Number CON-HL-390
Device Problem Power Problem (3010)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-390 is not powering up.No patient adverse events.
 
Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found wear and tear damage to drain fitting, enclosure, water tank cover, front cover, line cord, pole clamp, and 390 block.Functional testing was performed by filling the reservoir with water, attached temp check to hotline, plugged in line cord, and turned on power switch to perform safety/electrical testing.The reported problem was duplicated.The root cause was found to be a faulty printed circuit board.The printed circuit board was replaced.
 
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Brand Name
LEVEL ONE
Type of Device
WARMING
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12325229
MDR Text Key266681074
Report Number3012307300-2021-08432
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/16/2023
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 NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/13/2021
Initial Date FDA Received08/16/2021
Supplement Dates Manufacturer Received02/01/2023
Supplement Dates FDA Received02/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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