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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSIGNED 115V DOMESTIC HOTLINE; WARMER, THERMAL, INFUSION FLUID
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CONSIGNED 115V DOMESTIC HOTLINE; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Device Problems Device Alarm System (1012); No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 08/24/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical device has its disposable alarm going off and the display is blank.This was found during preventative maintenance.No patient was present.No adverse events reported.
 
Manufacturer Narrative
One fluid warmer was received for evaluation.Visual inspection of the device found a cracked enclosure and tank cover, an outdated pcb and power switch, and wear and tear damaged line cord and block assembly.A dhr review was performed subsequent to the manufacturing of the device and prior to its release; no problems or issues were identified during this dhr review.The device tank was filled with water and device was powered on.Functional testing confirmed the reported customer complaint as the micro switch is damaged causing the disposable alarm to sound and part of the lcd is disconnected from the pcb causing it to be blank.The problem source has been determined to be user interface.
 
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Brand Name
CONSIGNED 115V DOMESTIC HOTLINE
Type of Device
WARMER, THERMAL, INFUSION FLUID
MDR Report Key10556327
MDR Text Key207607199
Report Number3012307300-2020-09532
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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