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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR CONVECTIVE WARMING DEVICE; SYSTEM, THERMAL REGULATING

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ST PAUL LEVEL 1 EQUATOR CONVECTIVE WARMING DEVICE; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number SWU-2013
Device Problem Inadequate User Interface (2958)
Patient Problems Hemorrhage/Bleeding (1888); Low White Blood Cell Count (4433)
Event Date 06/01/2022
Event Type  Injury  
Event Description
It was reported that the patient was bleeding from neck, anesthetic had covered with a pressure dressing.Patient's hgb dropped from approximately 147 to approximately 76.At the end of the case, as drapes were removed, it was noted that the bottom chamber of the underbody snuggle warmer on the patients right side was full of blood, was just reaching the level where it was starting to spurt out of the air holes.It was then noted that the neck had been bleeding throughout the procedure-pressure dressing sopping wet, blood dripped down bleeding the neck and into the warming blanket.Intervention required transfusions of blood to the patient to combat the dropped hgb in the or, but was fine post op.Reporter indicated they had did not expect this as a possibility and wanted to make the reporting manufacturer aware, although they do not allege the device worked improperly.
 
Manufacturer Narrative
Other text: no lot or serial number was provided; therefore, device history record review could not be performed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.E4 is unknown in h10.
 
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Brand Name
LEVEL 1 EQUATOR CONVECTIVE WARMING DEVICE
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15201856
MDR Text Key297632650
Report Number3012307300-2022-15174
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier10610586043413
UDI-Public10610586043413
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K141686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSWU-2013
Device Catalogue NumberSWU-2013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/11/2022
Initial Date FDA Received08/10/2022
Supplement Dates Manufacturer Received09/13/2022
Supplement Dates FDA Received10/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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