Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVEL 1 FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LEVEL 1 FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number 8002910
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
It was reported that the air detector clamp control doesn't work on a smiths medical fluid warmer.No adverse patient effects were reported.
 
Manufacturer Narrative
Returned device was received in poor physical condition.The sensor block was broken and the door was not attached.H-2 has scratches on both but one is deeper then the other near the bottom of the door.No evidence of reported problem in event log was found.During the evaluation of the device, the sensor block in air detector is broken causing the clamp not to function.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL 1 FLOW FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
MDR Report Key10980601
MDR Text Key220628967
Report Number3012307300-2020-12248
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8002910
Device Catalogue Number8002910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-