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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD, INC. LEVEL 1 SYSTEM, THERMAL REGULATING Back to Search Results
Model Number L1-CW-120V
Device Problems Product Quality Problem (1506); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that a smiths medical l1-cart - won't mount. No patient involvement.
 
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Brand NameLEVEL 1
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11742972
MDR Text Key247899906
Report Number3012307300-2021-03559
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier15019517121551
UDI-Public15019517121551
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181699
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL1-CW-120V
Device Catalogue NumberL1-CW-120V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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