MAUDE Adverse Event Report: ST PAUL LEVEL ONE; WARMING

Catalog Number CON-HL-90

Device Problems Overheating of Device (1437); Failure to Calibrate (2440); Temperature Problem (3022)

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 goes into over temp and can't calibrate.Additional information received 4 august 2021 (email): issue discovered during testing.No patient involvement.

Manufacturer Narrative

H6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device presenting wear and tear damaged enclosure, front cover, and line cord, outdated pcb and power switch.The customer stated problem was duplicated.The over temp alarm sounded and stayed on.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The cause of the reported problem could not be determined.A manufacturing 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.

• Brand Name: LEVEL ONE
• Type of Device: WARMING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12380854
• MDR Text Key: 268643166
• Report Number: 3012307300-2021-08936
• 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
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2000
• 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