MAUDE Adverse Event Report: ST PAUL LEVEL ONE; WARMING

Catalog Number CON-HL-390

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-390 is not powering up.No patient adverse events.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).Manufacturing device history record 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 product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found wear and tear damage to drain fitting, enclosure, water tank cover, front cover, line cord, pole clamp, and 390 block.Functional testing was performed by filling the reservoir with water, attached temp check to hotline, plugged in line cord, and turned on power switch to perform safety/electrical testing.The reported problem was duplicated.The root cause was found to be a faulty printed circuit board.The printed circuit board was replaced.

• Brand Name: LEVEL ONE
• Type of Device: WARMING
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12325229
• MDR Text Key: 266681074
• Report Number: 3012307300-2021-08432
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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: 07/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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