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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 EQUATOR CONVECTIVE WARMER; SYSTEM, THERMAL REGULATING
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SMITHS MEDICAL ASD, INC. LEVEL 1 EQUATOR CONVECTIVE WARMER; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number EQ-5000
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Event Description
It was reported that the power turns on but does not work.They think there was something wrong with the hose.The fault occurred while checking before in use with the patient.There was no patient involvement and no harm/adverse event reported.
 
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.
 
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Brand Name
LEVEL 1 EQUATOR CONVECTIVE WARMER
Type of Device
SYSTEM, THERMAL REGULATING
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 Key19203523
MDR Text Key341291124
Report Number3012307300-2024-03158
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier50695085850005
UDI-Public(01)50695085850005(11)140218
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,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/29/2024
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 Other
Device Model NumberEQ-5000
Device Catalogue NumberEQ-5000JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2024
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/18/2014
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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