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 02/01/2024

Event Type  malfunction  

Event Description

It was reported that technical intervention was required as the device would not turn on.There was no patient involvement and no harm/adverse event reported.

Manufacturer Narrative

Date of event: unknown.No information has been provided to date.Initial reporter phone#: (b)(6).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

Evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found the device is in a good physical condition.Functional testing confirmed the complaint.Root cause was attributed a defective main board, which was replaced.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 LOW FLOW - HOTLINE 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18960550
• MDR Text Key: 338455837
• Report Number: 3012307300-2024-01607
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)080916
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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-90-IT-230
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2008
• 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