MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems No Audible Alarm (1019); Failure to Calibrate (2440); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the device had no audible alarm.Nothing "going off", display is not showing the correct number and was not calibrating.Patient involvement is unknown.

Manufacturer Narrative

Other text: b3: date of event and d4: udi section are 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

Other, other text: additional information is provided in g.1., h.2, h.3.And h.6.Evaluation codes: updated.Device evaluation: one device was received.A visual inspection found a cracked tank cover, faded line cord, outdated pcb and power switch.During the functional testing, the lcd and led's were found to be physically damaged as are the pots used to set the alarms.There was physical damage to the pcb with the probable cause being forcing on the front cover.No action was taken due to the condition and/or age of the device.It was deemed beyond economical repair and will be scrapped.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18231863
• MDR Text Key: 329458841
• Report Number: 3012307300-2023-10810
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1