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

Model Number HL-90

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Returned device was received with scratches on enclosure.Dirty in the water tank.Cracked front cover and water tank cover.Missing water tank cap, drain fitting, drain tube and drain tube cap.Old and worn line cord.Older style pcb and power switch.During the evaluation of the device the customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Event Description

It was reported that a fluid warmer won't power on, no adverse patient effects were reported.

• Brand Name: LEVEL 1 LOW FLOW 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10591268
• MDR Text Key: 208714881
• Report Number: 3012307300-2020-09872
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2020

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: No Information
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1