MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 LOW FLOW - HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.No information has been provided to date.Other operator of device: operator of device is unknown.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.

Event Description

It was reported that the power would not turn on prior to use.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

Evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found that there were missing rubber feet on the main unit.No abnormalities were found on the product's appearance that would fall under the reporting items.It was confirmed that the power did not turn on even when the power switch was turned on.Root cause was attributed to the failure of the power switch.Ac power switch were replaced.Also, attached the rubber feet that fell off.There is no repair history in the past for this device.The reported problem could not be related to previous icu medical repairs.D4 - udi and h4 - manufacture date.

• Brand Name: LEVEL 1 LOW FLOW - HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18772982
• MDR Text Key: 336627386
• Report Number: 2183161-2024-00170
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)190228
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: HL-90JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1