MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 CONVECTIVE WARMER - 220 VOLT CONFIGURATION; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L1-CW-220V
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.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 the device did not deliver heat and all lights come on.There was patient involvement, there was no harm/adverse event reported.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection found the device in used condition.Review of the event history log noted a 'distal error' a couple of times.Functional testing found an interruption in the cable to the thermistor.The l-1 hose was replaced.The device then passed all functional tests.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 CONVECTIVE WARMER - 220 VOLT CONFIGURATION
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20501247
• Report Number: 3012307300-2024-11582
• Device Sequence Number: 18049753
• Product Code: DWJ
• UDI-Device Identifier: 15019517121551
• UDI-Public: (01)15019517121551(11)190516
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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-220V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• 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