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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL LEVEL 1; HOTLINE LOW FLOW SYSTEM
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NULL LEVEL 1; HOTLINE LOW FLOW SYSTEM Back to Search Results
Catalog Number CON-HL-90
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
One fluid warmer was returned for evaluation.Visual inspection of the device found it to have a wear and tear damaged enclosure and line cord, outdated pcb, power switch, and front cover.A dhr review was performed subsequent to the manufacturing of the device and prior to its release; no problems were identified during this dhr review.Device tank was filled with water and powered on.The reported product complaint was confirmed as the buttons on the membrane switch are damaged from regular use and the enclosure near the drain fitting has started to crack.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The problem source has been determined to be user interface.
 
Event Description
Information was received that front membrane needs to be change and the drain pipe replaced; noted during preventive maintenance cycle.
 
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Brand Name
LEVEL 1
Type of Device
HOTLINE LOW FLOW SYSTEM
Manufacturer (Section G)
NULL
MDR Report Key10419841
MDR Text Key203301761
Report Number3012307300-2020-08247
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 08/18/2020
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 Health Professional
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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