MAUDE Adverse Event Report: SMITHS MEDICAL LEVEL 1 CONVECTIVE WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L1-CW-100VJP
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that during use, the tool mark indicator and the blockage mark indicator were not working.No health consequences to the patient were reported.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.The customer's reported problem was verified by functional testing.After turning on the power, the unit will blow air, but upon pressing the temperature setting button, an alarm will sound during heating and operation will stop.The cause is unknown.The hose itself was checked, but no breaks or abnormalities in the thermistor resistance were found.The hose was replaced to correct the issue.The device passed all functional tests after repair.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19651772
• Report Number: 3012307300-2024-05697
• Device Sequence Number: 6587420
• Product Code: DWJ
• UDI-Device Identifier: 15019517121551
• UDI-Public: (01)15019517121551(11)210226
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: L1-CW-100VJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/06/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown