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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL LEVEL 1; WARMER, THERMAL, INFUSION FLUID
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NULL LEVEL 1; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number CON-HL-90
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
One smiths medical level 1 hotline low flow system was returned for analysis with a cracked tank cover, wear and tear damaged enclosure, front cover and line cord, outdated printed circuit board (pcb) and power switch.During analysis, the reported issue was able to be duplicated.It was noted that faulty float switch was the cause of the reported issue.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.
 
Event Description
Information was received indicating that a smiths medical level 1 hotline low flow system was reading low reservoir but had a full tank.No adverse effects were reported.
 
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Brand Name
LEVEL 1
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section G)
NULL
MDR Report Key11349382
MDR Text Key232574853
Report Number3012307300-2021-01373
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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