MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-390

Device Problems Display Difficult to Read (1181); Optical Problem (3001)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information received a smiths medical warming|level 1 hotline low flow systems - hl-390 broken lcd screen.No patient adverse events reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A sample was received to perform an investigation.A visual inspection of the returned warmer found wear and tear damage to the front cover and line cord.Event history log review was not applicable.Functional testing was performed by filling the reservoir with water, attaching the temperature check to hotline, plugging in the line cord, and turning on the power switch to perform safety and electrical testing.The reported problem was confirmed.The liquid crystal display (lcd) was damaged.The cause of the damage was related to user interface.The printed circuit board (pcb) was replaced due to the damaged lcd screen and performed preventive maintenance.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11979453
• MDR Text Key: 258910448
• Report Number: 3012307300-2021-05873
• Device Sequence Number: 1
• Product Code: LGZ
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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 Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1