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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR BLOWERS

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ST PAUL LEVEL 1 EQUATOR BLOWERS Back to Search Results
Model Number EQ-5000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  Injury  
Event Description
It was reported that after the use of the product, the customer noticed the patient got a burn injury.
 
Manufacturer Narrative
One unit was returned for investigation. Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests. A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.
 
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Brand NameLEVEL 1 EQUATOR BLOWERS
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
2-12-12, kitanagase-omotemachi
minneapolis, MN 55442
MDR Report Key13366695
MDR Text Key284522508
Report Number3012307300-2022-01899
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier50695085850005
UDI-Public50695085850005
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K011907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEQ-5000
Device Catalogue NumberEQ-5000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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