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

Model Number HL-90

Device Problem No Display/Image (1183)

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

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

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 after an over temp test, the warmer the display went dead.Additional information received on mar 23, 2023 via email: the event occurred in biomed office, the event happened on (b)(6) 2023 and the medical intervention was no.

Manufacturer Narrative

One device was received and looked to be in very good condition.No physical damage was noted.Put water in the tank, attached temperature check, plugged line cord into outlet, turned device on.Could not duplicate the reported issue as the liquid crystal display (lcd) would not stabilize and kept fluctuating.The root cause was due to a faulty liquid crystal display (lcd) and/or printed circuit board (pcb).A device history record (dhr) review indicated the liquid crystal display (lcd) and printed circuit board (pcb) operated as intended and displayed accurate temperature reading during assembly and all functional tests passed.Replaced printed circuit board (pcb).Performed preventative maintenance (pm) and calibrated the device.All functional tests passed.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16722236
• MDR Text Key: 313113543
• Report Number: 3012307300-2023-03927
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• 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: 06/02/2023

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: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: 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
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1