• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND 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
 

SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Event Description
It was reported that during testing, there was a continuous low water alarm.There was no patient involvement and no patient harm adverse event reported.
 
Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: the affected device was returned for evaluation in good condition.After visual inspection, put water in water tank, attached disposable temp check, plugged line cord into outlet and connected to electrical analyzer and turned device on.The alarm that sounded was for disposable and not for low water.The customer's complaint was not replicated.However, the root cause for the disposable alarm was due to the microswitch missing the lever arm.Replaced microswitch.Device passed all functional tests after repair.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18888773
MDR Text Key337489616
Report Number3012307300-2024-01292
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public(01)50695085820909(11)230523
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/20/2024
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 Other
Device Model NumberHL-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/26/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/14/2024
Initial Date FDA Received03/12/2024
Supplement Dates Manufacturer Received04/23/2024
Supplement Dates FDA Received05/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-