MAUDE Adverse Event Report: OAKDALE LEVEL ONE; WARMING

Catalog Number CON-HL-90

Device Problem Power Problem (3010)

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

Event Type  malfunction  

Event Description

Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-90 has no power additional information received 16 august 2021 (email): issue discovered during testing.No patient involvement.

Manufacturer Narrative

Correction- manufacturing site corrected in section g1.Device evaluation- the device was returned for evaluation.During testing the reported issue was confirmed; device did not power on.The issue was determined caused by damage to connection between printed circuit board and power switch.These components were from an older iteration that is no longer used in servicing; these components have since been updated.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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were performed.Tank cover was severely cracked.There was wear and tear damage to the enclosure, faded line cord, outdated printed circuit board (pcb) and power switch.The technician stared with a visual inspection then filled tank with water, attached temperature check, plugged in line cord, and turned on the power switch.The was no power.The technician removed the pcb to investigate further.The root cause of the reported issue was found to be that the connection between the power switch and pcb was due to the design and damaged by the customer.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.A corrective and preventative action has been opened to address the reported issue.

• Brand Name: LEVEL ONE
• Type of Device: WARMING
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 3350 granada ave n; oakdale, MN 55128
• MDR Report Key: 12426274
• MDR Text Key: 270114261
• Report Number: 3012307300-2021-09184
• 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
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1